{"paper_id":"5add8e5c-92aa-4aa6-a35f-ce39990e9650","body_text":"~ 1261 ~ \nInternational Journal of Clinical Obstetrics and Gynaecology 2025; 9(6): 1261-1268 \n \nISSN (P): 2522-6614 \nISSN (E): 2522-6622 \nIndexing: Embase \nImpact Factor (RJIF): 6.71 \n© Gynaecology Journal \nwww.gynaecologyjournal.com \n2025; 9(6): 1261-1268 \nReceived: 15-08-2025 \nAccepted: 20-09-2025 \n \nDr. Franklin José Espitia De La \nHoz \nScientific Officer: Hathor, Clínica \nSexológica Armenia (Quindío, \nColombia), Department of \nUrogynecology and Pelvic Floor \nReconstructive Surgery, Urogolyn \nCare, Armenia, Quindío, Colombia \n \nDr. José Luis Neyro \nBilbao Academy of Medical \nSciences (Acmb) - Spain \nInternational Master&#39;S \nDegree In Climaterium And \nMenopause. University of Madrid \n(Udima), President of the Ibero-\nAmerican Society of Osteology and \nMineral Metabolism, Sibomm. \n \nDr. A Lilian Orozco Santiago \nMedicina Interna, Universidad El \nBosque, Bogotá, Colombia \nHematología, Fundación \nUniversitaria De Ciencias De La \nSalud (Fucs), Bogotá, Colombia \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \nCorresponding Author: \nDr. Franklin José Espitia De La \nHoz \nScientific Officer: Hathor, Clínica \nSexológica Armenia (Quindío, \nColombia), Department of \nUrogynecology and Pelvic Floor \nReconstructive Surgery, Urogolyn \nCare, Armenia, Quindío, Colombia \n \nEvaluation of the efficacy and safety of drospirenone in \nwomen with endometriosis \n \nFranklin José Espitia De La Hoz, José Luis Neyro and A Lilian Orozco \nSantiago \n \nDOI: https://www.doi.org/10.33545/gynae.2025.v9.i6g.1787  \n \nAbstract \nIntroduction: Endometriosis is an inflammatory, chronic, debilitating, high -incidence condition with \nserious consequences for women's reproductive, quality of life and sexual health. \nObjective: To determine the efficacy and safety of drospirenone when compared to Dienogest / Estradiol \nValerate, in the treatment of endometriosis pain, and its influence on sexual function.  \nMaterials and Methods:  A randomized, contro lled, triple -blind, multicenter clinical trial. We included \n185 women, aged 18 to 39, diagnosed with endometriosis. In fifteen institutions of medium and high \ncomplexity, in the Eje Cafetero, Colombia. 94 were administered drospirenone (DRSP) (experimental  \ngroup), and 91 received Dienogest / Estradiol Valerate (VE/DNG) (control group); between 2020 and \n2025. They were followed up three times, every 8 weeks. Descriptive statistics were performed.  \nOutcomes: At 24 weeks, pain relief was observed in both group s: 75.53% (DRSP) and 71.42% (VE/DNG) \n(p>0.05). The decrease in pain was accompanied by an improvement in sexual function, with increased \nsexual desire, excitation/lubrication in both groups ( p>0.05). Regarding adverse effects, no significant \ndifferences we re observed between groups (24.46% versus 20.87%; p = 0.81), whose intensity was \nconsidered “mild” by the patients. There was no superiority or inferiority of DRSP versus the combination \nof VE/DNG in efficacy, safety, tolerability, and satisfaction (p>0.05). \nConclusions: DRSP is effective for the treatment of endometriosis pain, and it is similar to the \ncombination of VE/DNG, with no significant difference in incidence of adverse effects. More randomized \nclinical trials evaluating the positive influence of drospirenone are required. \n \nKeywords: Hormonal contraception, sexual behavior, dyspareunia, endometriosis, efficacy, progestins \n \nIntroduction  \nEndometriosis is defined as a benign inflammatory, estrogen-dependent disease characterized by \nthe presence of f unctioning ectopic endometrial glands and stroma; insidious in onset, surgical \ndiagnosis, and usually progressiv e and debilitating in nature [1]. It usually affects women  in the \nreproductive stage [1, 2]. \nThe prevalence of endometriosis varies according to  the way the diagnosis is ma de, ranging \nfrom 1.5% to 15% [3]. \nThe pathogenesis of endometriosis is unknown; however, it points to retrograde menstruation \n(implantation theory), metaplasia of the germinal epithelium (celomic metaplasia theory), \nmetastatic dissemination (lymphocytic and hematogenous metastasis theory), altered immunity, \nstem cells, and genetic origins; but none of the theories alone could explain the enigmatic \nbehavior of the disease, yet the theory of retrograde menstruation is the most widely accepted \nworld-wide [2, 4]. \nThe clinical manifestations of endometriosis are both unpredictable and different; being the \nmain cause of chronic pelvic pain, there is no correlation between the degree of end ometriosis \nand the symptoms [5]. In some women, symptoms may develop early in adolescence  and persist \nafter menopause [6]. The most common symptoms associated with chronic pelvic pain are \ndysmenorrhea (80%) and deep dyspareunia (30%) [2, 6, 7]. \nClinical history allows suspicion, although clinical examin ation does not provide a definitive \ndiagnosis of endometriosis, but pain in vaginal examination, painful nodules in the back of the \nsac, adnexal masses, and immobility of the uterus, particularly in fixed retroversio n, are \ndiagnostic indicators [8]. The go ld standard in definitive diagnosis is direct visualizatio n by \nlaparoscopy or laparotomy [9, 10], with biopsy and histological confirmation [10]. \n\n\nInternational Journal of Clinical Obstetrics and Gynaecology https://www.gynaecologyjournal.com \n~ 1262 ~ \nSuppression of ovarian function may reduce disease and pain \nactivity [11]. Medical treatment is aimed at sup pressing estrogen \nsynthesis, inducing atrophy of the ectopic endometrium, or \ninterrupting the stimulation cycle and bleeding; Combined \nhormonal contraceptives (cyclically or continuously) and \ncontinuous progestogens (medroxyprogesterone acetate, \nnorethisterone, cyproterone acetate, dienogest or levonorgestrel -\nreleasing intrauterine system (LNG-IUS) are effective [11, 12]. \nDrospirenone (DRSP) is a synthetic progestin belonging to the \nspironolactone group, which has anti -mineralocorticoid, anti -\nestrogenic, anti-androgenic, and anti-gonadotropic properties [12]. \nDrospirenone / ethinyl estradiol has been shown to be more \neffective in treating endometriosis, compared with placebo, in \nimproving dysmenorrhea, pelvic pain, dysp areunia and quality \nof life [13].  \nNo clinical trials have been published regarding the use of DRSP \nas an individual treatment in endometriosis; and since \nsymptomatic endometriosis can cause negative long-term effects \non personal relationships, quality of l ife, and labor productivity \n[11]; it w as decided to carry out this research, with the aim of \nevaluating the efficacy and safety of 4 mg of drospirenone each \nday in the treatment of endometriosis, in addition to knowing its \ncontraceptive efficacy, adverse effects and influence on sexual \nfunction.  \n \nMaterials and Methods \nDesign and population: A randomized, controlled, triple -blind, \nmulticenter trial. Women aged 18 to 39 years with diagnosis of \nendometriosis confirmed by histology and future reproductive \ninterest were included; between July 01, 2020, and June 30, \n2025, in the contraception and family planning program of 15 \ninstitutions of medium and high complexity. In the Eje Cafetero, \nColombia, they serve population belonging to the contributory \nand subsidized regime of the General Social Secur ity System in \nColombia. We excluded women with a diagnosis or history of \nSTIs, a history of pelvic surgery or cancer, with genital \nmalformations or deformities, abortion or childbirth less than \none year, contraindications to receiving hormonal \ncontraceptives, and those who did not agree to participate. \n \nSample size and sampling:  A sample size of 152 women was \nestimated. The sample was calculated based on an expected \nefficacy for drospirenone of 70%, and 90% for the combination \nof Dienogest / Estradiol Valer ate; a significance level of 0.05 \nand a power of 80%, an estimate of 76 women per group was \nestablished. Randomization was done using a random number \nchart. The triple blind was guaranteed by masking the \nintervention both to patients and to researchers and  to \nstatisticians and epidemiologists who interpreted the results. The \nrandom assignment code generated, using sealed opaque \nenvelopes with a serial number each, was hidden; each envelope \ncontained a card indicating the treatment to which the patient \nwas assigned; those who were opened by a professional nurse, \noutside the study, once the woman signed informed consent to \nparticipate in the research. \n \nProcedure: Women who participated in contraception and \nfamily planning program with confirmed diagnosis of \nendometriosis (in the 15 institutions), were invited to collaborate \nin the study. Once the selection criteria were verified, and after \nthe signature of the informed consent document, they completed \nan Excel survey which recorded the sociodemographic and \nclinical characteristics of the participants, the nurse in charge \nhanded them out an envelope with the medication. \nIntervention: Two groups were assigned: drospirenone (DRSP) \n(experimental group, n=94) and Dienogest / Estradiol Valerate \n(VE/DNG) (control group , n=91). The women were \nadministered the dosage during the 24 weeks of the study. Those \nassigned to the experimental group (DRSP) were given a 4 mg \noral drospirenone tablet daily for 24 days plus 4 days of placebo \nto complete the 28 -day cycle; while the co ntrol group \n(VE/DNG) received 2 tablets of 3 mg estradiol valerate, 5 tablets \nof 2 mg estradiol valerate with 2 mg dienogest, 17 tablets of 2 \nmg estradiol valerate with 3 mg dienogest, 2 tablets of 1 mg \nestradiol valerate and 2 tablets of placebo to complete the 28-day \ncycle. The contraceptive pill was taken at bedtime. All women \nwere followed up three times, 8 weeks later, 16 and 24 weeks \nafter the start of the study. Follow -up was performed by a \ncontraceptive specialist that was not part of the study. \n \nVariables measured : Sociodemographic (age, race, marital \nstatus, educational level, occupation, place of origin, type of \nsocial security (subsidized, contributory, linked); size, weight, \nBody mass index (BMI); habits (smoking, alcohol use, \npsychoactive subst ance use, sedentary lifestyle); gynecologic -\nobstetric history (age of menarche, number of pregnancies, \nparity, contraceptive use in the last year); sexual behaviors \n(sexual orientation, age of onset of sexual life, average monthly \nfrequency of sexual intercourse, number of sexual partners, time \nof cohabitation); evolution of diagnosis of endometriosis and \nintake of non -steroidal anti -inflammatory drugs (NSAIDs) to \nmodulate pain. Contraceptive efficacy, safety, tolerability, \nsatisfaction, and adverse effects  were assessed. The Visual \nAnalogue Scale (VAS) and the time improvement of symptoms. \nThe domains of the FSFI (Female Sexual Function Index) \ninstrument: Desire, Excitation, Lubrication, Orgasm, \nSatisfaction and Pain.  \n \nEffectiveness evaluation: Each of the  women was followed up \nclinically and evaluated at each control: \na) Pain intensity:  by means of the Visual Analogue Scale \n(VAS). \nThe Visual Analogue Scale (VAS) of pain (14) allows the \nintensity of pain described by a person to be measured, with \nmaximum reproducibility among observers. It is represented \nby a horizontal line of 10 centimeters, at whose ends are the \nextreme expressions of a symptom. On the left -hand side \nthe absence or lower intensity is located and on the right -\nhand side the greater intensity. The patient is asked to mark \non the line the point that considers intensity and is measured \nwith a millimeter ruler. The intensity is expressed in \ncentimeters or millimeters. The rating is: \n1) Mild pain: If the patient scores the pain as less than 3. \n2) Moderate pain: If the score is between 4 and 7. \n3) Severe pain: Whether the score is equal to or greater than \n8. \n \nb) Rescue medication intake: Was evaluated based on the \nnumber of patients and number of doses of NSAIDs consumed \nby self-medication during the follow-up period. \n \nc) Sexual function:  with the Female Sexual Function Index \n(FSFI). \nThe FSFI is a 19 -item questionnaire, which groups six domains \n(Desire, Excitation, Lubrication, orgasm, Satisfaction and Pain); \neach question has 5 or 6 answer options, with a vari able score of \n0 to 5 [15]. The total score is obtained by the arithmetic sum of \nthe products obtained by multiplying the average of each domain \n\nInternational Journal of Clinical Obstetrics and Gynaecology https://www.gynaecologyjournal.com \n~ 1263 ~ \nby a factor [16]. The total range of the score ranges from 2 to 36; \na score less than or equal to 26.55 points, or when a domain \nscore is less than 3.6 points, it is considered at ris k for sexual \ndysfunction [15, 16]. \n \nSafety assessment: This was done by assessing the incidence of \nadverse effects in each control. The causality categories \ndescribed by the technical f undamentals of the Uppsala \nMonitoring Center (UMC), a WHO collaboratin g center for \npharmacovigilance [17], were retained, which classifies the \nclinical intensity of an adverse reaction as follows:  \n Mild: Signs and symptoms can be easily tolerated when the \npatient is distracted, may miss the symptoms and they \ndisappear. \n Moderate: Symptoms cause discomfort but are tolerable; \nthey cannot be overlooked and alter the concentration of the \nsubject. \n Severe: Symptom’s daily activities. \n \nTolerability assessment: The patient evaluated the treatment, at \neach control, using a qualitative print scale that inc luded the \nfollowing options [18]: \n Very good: No adverse drug reactions (ADRs). \n Good: ADRs do not significantly interfere with patient \nactivity. \n Regular: ADRs significantly interfere with normal patient \nactivity. \n Poor: ADRs surpass the therapeutic effect. \n \nSatisfaction assessment: It was done through: \na) Overall evaluation of treatment ( efficacy/tolerability) by a \ncontraceptive specialist (non -study), at each control, usin g \nthe overall clinical impression scale, which combines \ntherapeutic effect and adverse effects in a double -entry \npicture.  \nb) Evaluation of treatment effectiveness by the patient, at each \ncontrol, using a qualitative print scale that included the \noptions: \n Very effective:  Significant improvement, complete or \nalmost complete remission of symptoms. \n Effective: Marked improvement, partial remission of \nsymptoms. \n Moderately effective:  Weak improvement that does not \nalter the patient's condition. \n Ineffective: No changes or worsening. \n \nStatistical analysis : It was performed with the SPSS V21.0 \nprogram. For categorical variables, frequency tables were \ndeveloped with percentage analyses, for the continuous, \nanalyzes of central tendency and dispersion (mean and standard \ndeviation (SD) or medium and range) were performed. The two \ngroups were compared using the χ 2 test or Fisher's exact test in \ncategorical variables, and Student's t -test in continuous \nvariables. Statistical significance was defined as p<0.05. \n \nEthical aspects:  The study was approved by the Ethics \nCommittee of each participating center. The requirements for \nmedical research in human beings established in the Helsinki \nDeclaration were met. All participants signed the informed \nconsent. Confidentiality of information was guaranteed. \n \nOutcomes \nDuring the study period, 2624 women attended the \nContraception and Family Planning programs of the 15 \nparticipating institutions, of which 236 (8.99%) had diagnosis of \nendometriosis confirmed by histology, 14 (5.93%) did not agre e \nto participate. 37 patients were excluded: 12 with a diagnosis or \nhistory of STIs, 10 with a history of pelvic surgery, 8 with \nabortion or childbirth less than one year, and 7 with a history of \ncancer. The study was conducted with 185 patients (94 were \ngiven drospirenone -experimental group -, and 91 Dienogest / \nEstradiol Valerate -control group-). \nThe mean age was 32.31 ±5.06 and 31.84 ±3.97 years, \nrespectively ( p>0.05). 80.54% came from the urban area; \n86.48% professed the christian faith; 93.51% were straight and \n89.72% belonging to the State contributory regime in the \nGeneral Social Security System in Colombia. There were no \ndifferences between the groups in terms of sociodemographic \ncharacteristics (Table 1). \n \nTable 1: Sociodemographic characteristics in women with endometriosis, Eje Cafetero, Colombia, 2020 - 2025 \n \nVariables Drospirenone (n=94) Dienogest / Estradiol Valerate (n=91) p level \nAge: ẍ±SD years 32.31±5.06 31.84±3.97 p>0.05 \nAge of partner: ẍ±SD years 34.49±3.58 33.75±3.14 p>0.05 \nHeight: ẍ±DE Cms 158.32 (± 7.54) cm 157.93±7.38 p>0.05 \nẍ±DE Kg 61.45±4.53 60.73±4.61 p>0.05 \nBMI: ẍ±SD 24.41±3.61 24.15±3.42 p>0.05 \nRace \nWhite 50 (53.8 9 %) 48 (52.74 %) p>0.05 \nAfro-Colombians 37 (39.36 %) 39 (42.85 %) p>0.05 \nIndigenous 7 (7.44 %) 4 (4.39 %) p>0.05 \nSocioeconomic status \nHigh 31 (32.97 %) 33 (36.26 %) p>0.05 \nMiddle 54 (57.44 %) 48 (52.74 %) p>0.05 \nLow 9 (9.57 %) 10 (10.98 %) p>0.05 \nCivil Status \nMarried 34 (36.17 %) 31 (34.06 %) p>0.05 \nCommon law 38 (40.42 %) 35 (38.46 %) p>0.05 \nSingle 15 (15.95 %) 19 (20.87 %) p>0.05 \nDivorced 7 (7.44 %) 6 (6.59 %) p>0.05 \nOccupation \nStay-at-home spouses 41 (43.61 %) 42 (46.15%) p>0.05 \nEmployed 29 (30.85 %) 27 (29.67 %) p>0.05 \n\nInternational Journal of Clinical Obstetrics and Gynaecology https://www.gynaecologyjournal.com \n~ 1264 ~ \nUnemployed 24 (25.53 %) 22 (24.17 %) p>0.05 \nLevel of education \nPrimary 5 (5.31 %) 7 (7.69 %) p>0.05 \nSecondary 44 (46.81 %) 43 (47.25 %) p>0.05 \nTechnical 17 (18.08 %) 16 (17.58 %) p>0.05 \nProfessionals 28 (29.78 %) 25 (27.47 %) p>0.05 \nSource: authors \n \nThe 18.37% of women smoked, with a median consumption of 3 \n(range between 1 and 12) cigarettes/day; 74.59% consumed \nalcohol, and 5.94% consumed psychoactive substances; \nsedentary lifestyle was  present in 25.94%, with no differences \nbetween groups (p>0.05). \nThe age of menarche was 12.47 ±3.58 years (minimum 9 and \nmaximum 19), and the age of onset of sexual life was \n16.83±2.94 years (minimum 13 and maximum 23); the number \nof pregnancies reported a median of 3 (range between 0 and 7), \nparity returned a median of 2 (range between 0 and 5). \nIn the use of contraceptive methods, the use of oral hormonal \ncontraceptives (69.72%) prevailed in the last year, followed by \nthe subdermal implantation of LNG  (19.45%). The average \nfrequency of monthly sex was 2 (range 0 -5); the number of \nsexual partners was 7 (range 1 - ≥12); the average time of \ncohabitation was 5.83±2.17 years (minimum 1 and maximum 9). \nThe 58.37% of patients reported predating oral sex to \nintercourse, and 3.24% reported preferring anal sex, due to less \npain. \nThe average duration of endometriosis was 7.29 ±4.14 and \n8.13±4.37 years in each group. In most (71.35%) of the \nparticipants, pain was in the left iliac fossa. In the total \npopulation, the median number of pain attacks per year, \nrequiring institutional medical management, was 2 (range 0-4).  \nIn the symptoms of the total participants, dysmenorrhea \n(85.94%) prevailed, followed by dyspareunia (68.1%) and \nchronic pelvic pain (60.54%) (Table 2). \n \nTable 2: Symptoms of endometriosis in women, Eje Cafetero, Colombia, 2020 - 2025 \n \nSymptoms Drospirenone (n=94) Dienogest / Estradiol Valerate (n=91) p \nMenstrual disorders 65 (68.08 %) 60 (65.93 %) p>0.05 \nDysmenorrhea 78 (82.97 %) 81 (89.01 %) p>0.05 \nDyspareunia 66 (70.21 %) 60 (65.93 %) p>0.05 \nDisquiecy 4 (4.25 %) 2 (2.19 %) p>0.05 \nCyclical abdominal pain 36 (38.29 %) 33 (36.26 %) p>0.05 \nLower back pain 9 (9.57 %) 7 (7.69 %) p>0.05 \nChronic pelvic pain 59 (62.76 %) 53 (58.24 %) p>0.05 \nConstipation 17 (18.08 %) 14 (15.38 %) p>0.05 \nHematoquia 5 (5.31 %) 3 (3.29 %) p>0.05 \nInfertility 27 (28.72 %) 24 (26.37 %) p>0.05 \nRectal bleeding 2 (2.12 %) 3 (3.29 %) p>0.05 \nUrinary symptoms 24 (25.53 %) 27 (29.67 %) p>0.05 \nSource: authors \n \nOn admission, according to the Visual Analogue Scale (VAS) of \npain, in the drospirenone group (DRSP) 79.78% reported pain as \nmoderate intensity (VAS >4 and ≤7); In 14.89% of women as \nsevere (VAS ≥8), only 5.31% of women described pain as mild \n(VAS <3). In the VE/DNG group, 84.61% reported pain as \nmoderate intensity; 12.08% as severe; and 3.29% as mild (EVA \n<3); no statistically significant difference ( p>0.05). At the end \nof the study, an improvement of 75.53% and 71.42% was \nobserved, respectively ( p>0.05), where there was a complete \nabsence of pain; only 9 (9.57%) in the DRSP group and 10 \n(10.98%) in the VE/DNG group rated pain as “moderate”; 14 \n(14.89%) and 1 6 (17.58%), respectively, rated it as mild; no \npatient considered pain to be “severe”. \nAt 24 weeks, the percentage of complete remission of \ndysmenorrhea was 71.27% for the DRSP group and 70.32% for \nthe VE/DNG group (p>0.05). Dyspareunia improved by 70.21% \nand 75.82%, respectively (p>0.05).  \nWomen in the DRSP group had a longer average time between \nadministration of the drug and improvement of dysmenorrhea \n(8.31±2.79 weeks), with no significant difference with the \nVE/DNG group (8.04±2.58 weeks) (p = 0.123). \nIn the DRSP group, 10 women (10.63%) warranted the use of \nNSAIDs to modulate pain (RR: 0.42; CI 95%: 0.18 -0.75) and 5 \nof 91 in VE/DNG group (RR: 0.18; CI95%: 0.12 -0.69). The \nincreased risk of needing NSAIDs was further increased in \nnulligestants (RR: 1 .26; CI95%: 1.08 -2.07) and married women \n(RR: 1.11; CI95%: 1.02 -20.4); the difference was not \nstatistically significant (p = 0.072). \nAt the end of the study, in the DRSP group, 65 (69.14%) women \nshowed an increase in the median monthly sexual frequency (4;  \nrange between 2 and 6 vs. 3; range 1 to 7 (VE/DNG), with no \nstatistically significant difference (p = 0.93). The IFSF score was \n28.14±3.57 (DRSP) and 27.93±4.26 (VE/DNG), (p>0.05).  \nAt baseline, the IFSF score, less than 26.55 points, was observed \nin 70.81% of the total patients, a percentage that decreased at the \nend of the study to 36.21%, with no significant differences \nbetween groups (38.29% versus 34.06%, p>0.05). \nThere were no statistically significant differences between \ngroups in the positive i nfluence of contraception on sexual \nfunction (79.78% versus 81.31%) (p = 0.18) (Table 3).  \n \n\nInternational Journal of Clinical Obstetrics and Gynaecology https://www.gynaecologyjournal.com \n~ 1265 ~ \nTable 3: Female sexual function index, in women with endometriosis, Eje Cafetero, Colombia, 2020 - 2025 \n \nDomains Contraception Baseline 8 weeks 16 weeks 24 weeks P baseline vs. end \nDesire Drospirenone 3,04±1,06 3,49±1,08 4,09±1,15 4,17±1,13 p<0,05 \nDienogest 3,17±1,05 3,54±1,03 4,02±1,14 4,29±1,14 p<0,05 \nArousal Drospirenone 3,62±1,05 3,81±1,01 4,35±1,11 4,68±1,17 p<0,05 \nDienogest 3,61±1,02 3,79±1,05 4,39±1,17 4,62±1,15 p<0,05 \nLubrication Drospirenone 3,49±1,04 3,65±1,07 4,28±1,13 4,59±1,12 p<0,05 \nDienogest 3,57±1,02 3,71±1,08 4,32±1,19 4,56±1,11 p<0,05 \nOrgasm Drospirenone 3,71±1,04 3,84±1,09 4,59±1,28 4,83±1,14 p<0,05 \nDienogest 3,68±1,01 3,87±1,06 4,61±1,23 4,86±1,13 p<0,05 \nSatisfaction Drospirenone 3,95±1,52 4,19±1,43 4,72±1,39 4,75±1,11 p<0,05 \nDienogest 3,97±1,46 4,28±1,52 4,75±1,45 4,81±1,19 p<0,05 \nPain Drospirenone 5,32±1,08 5,03±1,29 4,81±1,42 4,17±1,17 p<0,05 \nDienogest 5,29±1,53 5,02±1,38 4,73±1,43 4,02±1,16 p<0,05 \nTotal Drospirenone 23,13±6,78 24,01±6,97 26,84±6,48 27,19±6,84 p<0,05 \nDienogest 23,29±7,09 24,21±7,12 26,82±7,61 27,16±6,88 p<0,05 \nSource: authors \n \nDepending on the presence or absence of adverse effects, no \nsignificant differences were obtained between the groups: \n24.46% (DRSP) versus 20.87% (VE/DNG), (p = 0.81), whose \nintensity was considered by the patients as “mild,” in both \ngroups, so no treatment or suspension of contraception was \nrequired. The most frequent adverse effect in the DRSP group \nwas amenorrhea, especially after 16 weeks, followed by \nirregular vaginal bleeding (Table 4). \n \nTable 4: Adverse effects of oral contraceptives, in women with endometriosis, Eje Cafetero, Colombia, 2020 - 2025 \n \nAdverse effects Drospirenone (n=94) Dienogest / Estradiol Valerate (n=91) p \nAcne 10 (10.63 %) 8 (8.79 %) p>0.05 \nAlopecia 5 (5.31 %) 3 (3.29 %) p>0.05 \nAmenorrhea 23 (24.46 %) 19 (20.87 %) p>0.05 \nWeight loss 12 (12.76 %) 10 (10.98 %) p>0.05 \nWeight gain 4 (4.25 %) 6 (6.59 %) p>0.05 \nMood changes 3 (3.19 %) 4 (4.39 %) p>0.05 \nHeadache 7 (7.44 %) 8 (8.79 %) p>0.05 \nEdema 8 (8.51 %) 7 (7.69 %) p>0.05 \nMastalgia 11 (11.7 %) 15 (16.48 %) p>0.05 \nIrregular vaginal bleeding 14 (14.89 %) 16 (15.28 %) p>0.05 \nSource: authors \n \nThe median adverse effects per woman were 2 (range 0 to 5), \nwhich was present in 22.7% (n=42/185) of the total participants; \n23.4 % (n=22/94) in the DRSP grou p, and 21.97% (n=20/91) in \nthe VE/DNG group, with no significant differences between the \ntwo (0.672).  \nIn the groups, a decrease was observed over time in the number \nof women with irregular bleeding or spotting, as well as in the \nnumber of unscheduled blee dings, especially after 16 weeks \n(40.42% vs. 43.95%), (p>0.05). \nTreatment tolerability in the DRSP group ranged from “very \ngood” (70.42%) to “good” (29,.57%), compared with 68.05% \nand 31.94%, respectively, in the VE/DNG group ( p>0.05). In \nany of the patien ts in both groups, tolerability was considered \n“regular” or “poor.” \nAt 24 weeks treatment satisfaction was rated as “effective” in \n75.53% of the DRSP group and 71.42% of the VE/DNG group \n(p>0.05). Of the 94 women in the DRSP group, in 7 (7.44%) \nsatisfaction was considered “ineffective,” while of the 91 \nparticipants in the VE/DNG group, “ineffective,” satisfaction \noccurred in 11 (12.08%) of them, with no statistically significant \ndifference (p = 0.27). \nDuring the study, no pregnancy occurred in either group. \n \nDiscussion.  \nProgestins have been used more often for the treatment of \nendometriosis, and in line with combinations of \nestrogen/progestin (low doses), they have become a first -line \ntherapy (19.20). Progestins are particularly advantageous in \nwomen with d ysmenorrhea [21], while combined oral \ncontraceptives are useful in treating pain and other symptoms \nassociated with endometriotic nodules [22]; although the \ntreatment guidelines of the American College of Obstetricians \nand Gynecologists  (ACOG), recommend c ombined extended -\ncycle oral contra ceptives as initial treatment [23]. \nPharmacokinetics, efficacy and tolerability of the combination of \nethinyl estradiol/drospirenone for contraception has bee n \nconfirmed by several authors [24-26]; this has provided a valu able \noption, by drospirenone, for additional treatment for women \nwith endometriosis. \nThis research found that, at 24 weeks, chronic pelvic pain \nshowed a significant reduction (75.53 %) with the use of \ndrospirenone, similar to the combination of VE/DNG (71. 42 %) \n(p>0.05); results that are similar to those reported by Vercellini \net al., who, in a two -year prospective, therapeutic, self -\ncontrolled clinical trial conducted in Italy, which included 50 \nwomen who had undergone endometriosis surgery, and they had \nexperienced recurrent dysmenorrhea despite the use of cyclic \noral contraceptives; they reported a significant reduction in \ndysmenorrhea with the continuous use of combined oral \ncontraceptives (ethinyl estradiol  20 μg and desogestrel 150 μg) \n[27]. Muzii et a l., in a meta -analysis that included three \nrandomized trials and a prospective controlled cohort study, for \na total of 557 patients with endometriosis, 343 of whom had \novarian endometriomas; they obtained lower recurrence rates for \ndysmenorrhea with a cont inuous program of continuous oral \ncontraceptives (RR: 0.24; CI95%: 0.06 - 0.91; p = 0.04) [28]. \n\nInternational Journal of Clinical Obstetrics and Gynaecology https://www.gynaecologyjournal.com \n~ 1266 ~ \nIf the main purpose of medical treatments for endometriosis is to \nrelieve pain, with adequate therapies for long -term use, in \naddition to being associated with a lo w incidence of adverse \neffects [11], in this regard, drospirenone in regimen 24/4, is a \nviable option, in the light of the results of this study.  \nSexual problems are common in women with endometriosis, as \nthey are at increased risk for dyspareunia com pared to the \nnormal population; affecting 11.5% (OR: 7.4; CI95%: 6.5 -8.5) \nof women [29]; may affect all domains of sexual function \n(desire/arousal, orgasm, satisfaction and pain), which led to \nsexual dysfunction in 70.81% of patients, as described in the \ntotal population of this study; percentage that decreased to \n36.21% at the end of the investigation, with no significant \ndifferences between groups (38.29% versus 34.06%, p>0.05).  \nAt the end of the study, drospirenone was associated with an \nincrease in med ian monthly sexual frequency, with an increase \nin satisfaction score; no statistically significant difference with \nthe VE/DNG combination (p = 0.93). Regarding these findings, \nseveral authors agree that combined oral contraceptives and \nprogestins are effec tive in relieving pelvic pain and deep \ndyspareunia in patients with endometriosis [30-32], which may be \nassociated with a positive experience in improving sexual \ndysfunction. \nOnce the comprehensive search has been conducted, we note \nthat our study is the f irst randomized controlled trial, evaluating \nregimen 24/4 for the control of chronic pelvic pain associated \nwith endometriosis. The results show that, compared with the \ncombination of VE/DNG, pain reduction was associated with \nimproved sexual function, wit h differences in IFSF scores \nstatistically significant at 24 weeks; there were no statistically \nsignificant differences between both groups (p = 0.18). \nThe adverse effects observed in this study are the same as those \nalready known and published by other re searchers [33-35]; \ntherefore, the safety profile is considered similar, with slight \npercentage differences, lacking statistical significance.  \nThis study indicated that there is no superiority or inferiority of \ndrospirenone in the 24//4 regimen compared wi th the VE/DNG \ncombination, with very similar satisfaction, safety and \ncontraceptive efficacy; therefore, it becomes an appropriate \nalternative in pain management in women with endometriosis; \nresults that are consistent with those published by Archer et al. \n[36], regarding clinical contraceptive efficacy similar to that of \ncombined oral estrogen plus progestin contraceptive, with a \ngood safety profile and favorable cycle control. \nIn his study,  Ludicke et al.,  with the combination of 30 μg \nethinyl estradiol / 3 mg drospirenone, demonstrated a good \nsuppression of endometrial activity and marked antiproliferative \neffect, comparable with othe r combined oral contraceptives [37]; \neffect we invite to evaluate in futu re research with the \ndrospirenone regimen 24/4, as it would become the cornerstone \nin choosing a progestin. \nAbout the patient satisfaction point of view, this study found that \nthere were no dropouts, which is like that published by Palacios \net al. [38], those who report 3.2% abandonment by women who \nreceived 4 mg of drospirenone, compared with 6.6% of those \nwho took 0.075 mg of desogestrel (p<0.001). \nComparing oral contraceptives combined with progestins alone, \nthe latter offer multiple advantages because t hey are associated \nwith a decreased risk of venous thromboembolism [36, 39] and \ncause fewer metabolic changes [40], this makes them an \nappropriate choice in women with intolerance or \ncontraindications to estrogens (migraine, cardiovascular risk \nfactors: HTA, hyperlipidemias, obesity, diabetes, smoking, etc.) \n[41-43]; which puts the drospirenone in a privileged position, since \naccording to Surrey et al. [32], progestagens have been used as the \nfirst therapy in the management of symptomatic endometriosis, \nas well as adjuvants to surgical resection. This has been \nconfirmed by both prospective observational studies and \nrandomized clinical trials [30, 32, 44]. \nRecently, in research (multicenter, open -label trial, phase 3), in \nEurope and Russia [45], sexually acti ve women (18 to 50 years), \nwith regular menstrual cycles and BMI ≤ 35 kg/m2; participants \nwere given estetrol (15 mg) / drospirenone (3 mg) in a regimen \nof 24 assets and 4 placebo for up to 13 cycles, with effective \ncontraception, a predictable bleeding pattern, and a favorable \nsafety profile. With this we can consider,  once again, that \ndrospirenone is not only one of the most effective \ncontraceptives, but one of the safest, either alone or combined. \nMore large-scale controlled clinical trials are needed to provide \nmore information on the efficacy and safety profile of \ndrospirenone in the treatment of endometriosis pain, as well as \nits eventual influence on sexual function. \nThe main strength of this study is that it covers an unexplored \naspect of the use of new progestins in the treatment of \nendometriosis, being the first  to use the drospirenone regimen \n24/4; in addition, by performing a simple random sampling, each \nof the women enjoyed equal opportunities to be selected. Sample \nsize is another important strength, due to the variable prevalence \nof the disease. Weaknesses i nclude the fact that a placebo -\ncontrolled trial is not offered to symptomatic patients, and that \nthere is currently no study where the medical treatment of \nendometriosis is drospirenone regimen 24/4, which can be used \nas a comparison; however, it is possib le to draw definitive \nconclusions to generalize the results, although the need for \nconfirmation/validation in larger series of patients is suggested.  \n \nConclusions. \nDrospirenone of 4 mg, with the regimen of 24/4, is effective in \nthe treatment of endometriosis, resulting like the combination of \nDienogest / Estradiol Valerate, with an incidence of adverse \neffects without significant differences, which are tolerable, \nwithout requiring discontinuation of the drug. Similarly, the \npositive influence on sexual fun ction is equivalent to the \ncombination of Dienogest / Estradiol Valerate. \nIt is necessary to individualize each woman, where hormonal \ntreatment for endometriosis should be used. Further studies \nevaluating the positive influence of drospirenone of 4 mg on t he \n24/4 regimen in our region are required, as there are often \nlimitations on access to non -invasive laparoscopic procedures. \nFuture randomized clinical trials may confirm the findings of \nthis research.  \n \nThanks \nTo each of the professionals of the particip ating clinics, to the \ndirectives of Hathor, Sexological Clinic, and to Dr. José \nFrancisco Espitia Hernandez, for their support in the revision of \nthe document; without whose contributions it would not have \nbeen possible to conduct this research. \n \nFunding \nThis study was funded by Hathor, Sexological Clinic; an \ninstitution that provided contraceptive medications. \n \nReferences \n1. International working group of AAGL, ESGE, ESHRE and \nWES, Tomassetti C, Johnson NP, Petrozza J, et al. An \nInternational Terminology for Endometriosis, 2021. 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Evaluation of the efficacy and \nsafety of drospirenone in women with endometriosis . International Journal \nof Clinical Obstetrics and Gynaecology 2025; 9(6): 1261-1268.  \n \n \nCreative Commons (CC) License \nThis is an open access journal, and articles are distributed under the terms \nof the Creative Commons Attribution -NonCommercial-ShareAlike 4.0 \nInternational (CC BY -NC-SA 4.0) License, which allows others to remix, \ntweak, and build upon the work non -commercially, as long as appropriate \ncredit is given and the new creations are licensed under the identical terms.","source_license":"CC0","license_restricted":false}