A Randomized, Parallel, Comparative Study of the Efficacy and Safety of Nafarelin Versus Danazol in the Treatment of Endometriosis in Taiwan

Cheng MH, Ming-Huei Cheng, Bill Ken-Jen Yu, Yu BK, Sheng-Ping Chang, Chang SP, Peng-Hui Wang, Peng‐Hui Wang, Wang PH
Journal of the Chinese Medical Association : JCMA · 2005 · vol. 68(7) , pp. 307–314 · doi:10.1016/s1726-4901(09)70166-2 · PMID:16038370 · W2011872572
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⚙ AI-generated summary by gemini-2.5-flash-lite, 2026-06-11 ⓘ

Nafarelin and danazol showed similar efficacy in treating endometriosis, but nafarelin had fewer laboratory changes and a more stable lipid profile.

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This randomized comparative study evaluated the efficacy and safety of intranasal nafarelin versus danazol in 59 women with laparoscopically confirmed endometriosis over a 180-day period. Both treatments effectively resolved pelvic pain, tenderness, and other symptoms without significant differences in overall clinical outcomes or adverse event rates. However, nafarelin demonstrated a more favorable safety profile by causing fewer changes in liver enzymes and maintaining stable lipid levels compared to danazol. This paper is centrally about endometriosis — specifically comparing two medical therapies for managing its symptoms and assessing their respective side effect profiles.

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Abstract

BACKGROUND: The purpose of this study was to evaluate the efficacy and safety of nafarelin, a gonadotropin-releasing hormone (GnRH) analogue, versus danazol in the treatment of women with endometriosis in Taiwan. METHODS: Fifty-nine women with laparoscopically and pathologically confirmed endometriosis were randomized to receive nafarelin or danazol for 180 days. Efficacy was assessed from mean changes in laparoscopy score (LS) and total symptom severity score (TSSS). Adverse events (AEs) and laboratory parameters, including hematology, hepatic function, blood pressure, and lipid levels, were monitored for safety evaluations. RESULTS: All demographic and baseline factors, except body weight, were comparable between the 2 treatment groups. Both nafarelin and danazol satisfactorily resolved pelvic tenderness, induration, pelvic pain, dysmenorrhea and dyspareunia. No significant differences were noted in efficacy endpoints between nafarelin and danazol regarding LS and TSSS at 90 and 180 days of treatment. No significant difference was observed between the 2 groups regarding the overall incidence of AEs, except for laboratory-related AEs. However, nafarelin tended to have less impact than danazol on aspartate transaminase and alanine transaminase, and nafarelin was better tolerated than danazol regarding changes in lipid profiles. Both treatments had little or no effect on hematologic parameters. CONCLUSION: Nafarelin and danazol demonstrated similar clinical efficacy, but nafarelin was associated with fewer laboratory changes and a stable lipid profile, relative to danazol. Moreover, intranasally administered nafarelin is noninvasive, and may be a more comfortable and safer alternative to slow-release injectable GnRH agonists. Based on this study, we suggest that nafarelin, like other GnRH analogues, may be a treatment of choice for Taiwanese women with endometriosis. However, direct comparative studies of nafarelin with slow-release injectable GnRH agonists are now required.
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Background

The purpose of this study was to evaluate the efficacy and safety of nafarelin, a gonadotropin-releasing hormone (GnRH) analogue, versus danazol in the treatment of women with endometriosis in Taiwan.

Methods

Fifty-nine women with laparoscopically and pathologically confirmed endometriosis were randomized to receive nafarelin or danazol for 180 days. Efficacy was assessed from mean changes in laparoscopy score (LS) and total symptom severity score (TSSS). Adverse events (AEs) and laboratory parameters, including hematology, hepatic function, blood pressure, and lipid levels, were monitored for safety evaluations.

Results

All demographic and baseline factors, except body weight, were comparable between the 2 treatment groups. Both nafarelin and danazol satisfactorily resolved pelvic tenderness, induration, pelvic pain, dysmenorrhea and dyspareunia. No significant differences were noted in efficacy endpoints between nafarelin and danazol regarding LS and TSSS at 90 and 180 days of treatment. No significant difference was observed between the 2 groups regarding the overall incidence of AEs, except for laboratory-related AEs. However, nafarelin tended to have less impact than danazol on aspartate transaminase and alanine transaminase, and nafarelin was better tolerated than danazol regarding changes in lipid profiles. Both treatments had little or no effect on hematologic parameters.

Conclusion

Nafarelin and danazol demonstrated similar clinical efficacy, but nafarelin was associated with fewer laboratory changes and a stable lipid profile, relative to danazol. Moreover, intranasally administered nafarelin is noninvasive, and may be a more comfortable and safer alternative to slow-release injectable GnRH agonists. Based on this study, we suggest that nafarelin, like other GnRH analogues, may be a treatment of choice for Taiwanese women with endometriosis. However, direct comparative studies of nafarelin with slow-release injectable GnRH agonists are now required.

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Condition tags

endometriosisdysmenorrheadyspareunia

MeSH descriptors

Danazol Endometriosis Nafarelin Adult Alanine Transaminase Alanine Transaminase Aspartate Aminotransferases Aspartate Aminotransferases Cholesterol, HDL Cholesterol, HDL Cholesterol, LDL Cholesterol, LDL Danazol Danazol Endometriosis Endometriosis Endometriosis Female Humans Liver

Citation neighborhood

Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

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