Comparative, open-label prospective study on the quality of life and sexual function of women affected by endometriosis-associated pelvic pain on 2 mg dienogest/30 µg ethinyl estradiol continuous or 21/7 regimen oral contraceptive

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Continuous dienogest/ethinyl estradiol oral contraceptives improved pain, quality of life, and sexual function more than a 21/7 regimen in women with endometriosis-associated pelvic pain.

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This prospective, open-label comparative study evaluated effects of a dienogest/ethinyl estradiol combined oral contraceptive given either continuously (2 mg dienogest/30 µg ethinyl estradiol) or in a 21/7 regimen on quality of life and sexual function in 96 women with endometriosis-associated pelvic pain, with endometriosis-associated pain assessed by Visual Analog Scale and QoL/sexual outcomes measured using SF-36, FSFI, and FSDS across two follow-ups. Women receiving the continuous regimen showed improvement in pelvic pain at 3 and 6 months and reported QoL improvements across all SF-36 categories at both follow-ups (p < 0.001), alongside increased FSFI total scores and decreased FSDS scores (p < 0.001). The 21/7 regimen group improved pain at the second follow-up and showed QoL improvements and sexual function/distress changes mainly at the second follow-up, with no early sexual distress improvement (p = NS). The main limitation explicitly implied by the design is open-label, and the paper reports effects only over two follow-ups. This paper is centrally about endometriosis-associated pelvic pain — it compares continuous versus 21/7 dienogest/ethinyl estradiol on QoL and sexual function in women with endometriosis.

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Abstract

PurposeTo evaluate the effects of a continuous regimen combined oral contraceptive (COC) containing 2 mg dienogest and 30 µg ethinyl estradiol (DNG/EE) compared to a 21/7 regimen on the quality of life (QoL) and sexual function in women affected by endometriosis-associated pelvic pain.MethodsSixty-three women constituted the Study group treated with DNG/EE COC continuous regimen; 33 women were given DNG/EE COC in a 21/7 regimen. To define the endometriosis-associated pelvic pain, the Visual Analogic Scale was used. The Short Form-36, Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) were used to assess QoL, sexual function and sexual distress, respectively. The study included two follow-ups.ResultsAt 3 and 6 months of treatment there was an improvement in pain of the Study group (p < 0.001). The Control group underwent pain improvement at the second follow-up (p < 0.05). At the first and the second follow-ups, the Study group reported QoL improvements in all categories (p < 0.001). The Control group reported QoL improvements in all categories at the second follow-up (p < 0.05). At the first and the second follow-ups of the Study group, the FSFI total score had risen (p < 0.001), and the FSDS score had dropped (p < 0.001). An improvement of the FSFI score and a reduction of the FSDS score of the Control group was observed at the second follow-up (p < 0.001), but not at the first follow-up (p = NS).ConclusionsWomen on DNG/EE COC continuous regimen reported a reduction of endometriosis-associated pelvic pain and there was an improvement of their sexual activity and their QoL that was better than the DNG/EE 21/7 conventional regimen.
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Abstract

Purpose To evaluate the effects of a continuous regimen combined oral contraceptive (COC) containing 2 mg dienogest and 30 µg ethinyl estradiol (DNG/EE) compared to a 21/7 regimen on the quality of life (QoL) and sexual function in women affected by endometriosis-associated pelvic pain.

Methods

Sixty-three women constituted the Study group treated with DNG/EE COC continuous regimen; 33 women were given DNG/EE COC in a 21/7 regimen. To define the endometriosis-associated pelvic pain, the Visual Analogic Scale was used. The Short Form-36, Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) were used to assess QoL, sexual function and sexual distress, respectively. The study included two follow-ups.

Results

At 3 and 6 months of treatment there was an improvement in pain of the Study group (p < 0.001). The Control group underwent pain improvement at the second follow-up (p < 0.05). At the first and the second follow-ups, the Study group reported QoL improvements in all categories (p < 0.001). The Control group reported QoL improvements in all categories at the second follow-up (p < 0.05). At the first and the second follow-ups of the Study group, the FSFI total score had risen (p < 0.001), and the FSDS score had dropped (p < 0.001). An improvement of the FSFI score and a reduction of the FSDS score of the Control group was observed at the second follow-up (p < 0.001), but not at the first follow-up (p = NS).

Conclusions

Women on DNG/EE COC continuous regimen reported a reduction of endometriosis-associated pelvic pain and there was an improvement of their sexual activity and their QoL that was better than the DNG/EE 21/7 conventional regimen. Similar content being viewed by others

References

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Int J Womens Health 5:613–617 Acknowledgments The authors wish to thank: The Scientific Bureau of the University of Catania, Italy, for language support. Author information Authors and Affiliations Corresponding author Ethics declarations Conflict of interest The authors declare that they have no conflict of interest. Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent Informed consent was obtained from all women included in the study. Rights and permissions About this article Cite this article Caruso, S., Iraci, M., Cianci, S. et al. Comparative, open-label prospective study on the quality of life and sexual function of women affected by endometriosis-associated pelvic pain on 2 mg dienogest/30 µg ethinyl estradiol continuous or 21/7 regimen oral contraceptive. J Endocrinol Invest 39, 923–931 (2016). https://doi.org/10.1007/s40618-016-0460-6 Received: Accepted: Published: Issue date: DOI: https://doi.org/10.1007/s40618-016-0460-6

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endometriosischronic_pelvic_pain

MeSH descriptors

Contraceptives, Oral, Combined Endometriosis Ethinyl Estradiol Nandrolone Pelvic Pain Quality of Life Sexual Behavior Adolescent Adult Case-Control Studies Contraceptives, Oral, Combined Endometriosis Estrogens Estrogens Ethinyl Estradiol Female Follow-Up Studies Humans Nandrolone Nandrolone

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