MedicGo
Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone-antagonist: a randomized clinical trial.
Metadata
Journalfertility and sterility6.312Date
2020 Jun 04
4 months ago
Type
Journal Article
Volume
2020-Jul / 114 : 44-55
Author
Donnez J 1, Taylor HS 2, Taylor RN 3, Akin MD 4, Tatarchuk TF 5, Wilk K 6, Gotteland JP 7, Lecomte V 7, Bestel E 8
Affiliation
  • 2. Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut.
  • 3. Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah.
  • 4. Austin Area Obstetrics Gynecology and Fertility, Austin, Texas.
  • 5. Department of Endocrine Gynecology, Institute of Pediatrics, Obstetrics and Gynecology of the NAMS of Ukraine, Kiev, Ukraine.
  • 6. Vita Longa Sp. z o.o, Katowice, Poland.
  • 7. ObsEva S.A, Geneva, Switzerland.
  • 8. ObsEva S.A, Geneva, Switzerland. Electronic address: [email protected]
Doi
PMIDMESH
Abstract
OBJECTIVE: To study the effect of a new investigational oral gonadotropin-releasing hormone antagonist, linzagolix, on endometriosis-associated pain (EAP).
DESIGN: A multinational, parallel group, randomized, placebo-controlled, double-blind, dose-ranging trial.
SETTING: Clinical centers.
PATIENT(S): Women aged 18-45 years with surgically confirmed endometriosis and moderate-to-severe EAP.
INTERVENTION(S): The interventions were 50, 75, 100, or 200 mg linzagolix (or matching placebo) administered once daily for 24 weeks.
MAIN OUTCOME MEASURE(S): The primary endpoint was the number of responders (≥30% reduction in overall pelvic pain) after 12 weeks. Other endpoints included dysmenorrhea, non-menstrual pelvic pain, serum estradiol, amenorrhea, quality of life (QoL) measures, and bone mineral density (BMD).
RESULT(S): Compared with placebo, doses ≥ 75 mg resulted in a significantly greater proportion of responders for overall pelvic pain at 12 weeks (34.5%, 61.5%, 56.4%, and 56.3% for placebo, 75, 100, and 200 mg, respectively). A similar pattern was seen for dysmenorrhea and non-menstrual pelvic pain. The effects were maintained or increased at 24 weeks. Serum estradiol was suppressed, QoL improved, and the rate of amenorrhea increased in a dose-dependent fashion. Mean BMD loss (spine) at 24 weeks was <1% at doses of 50 and 75 mg and increased in a dose-dependent fashion up to 2.6% for 200 mg. BMD of femoral neck and total hip showed a similar pattern.
CONCLUSION(S): Linzagolix significantly reduced EAP and improved QoL at doses of 75-200 mg and decreased BMD dose-dependently.
CLINICAL TRIAL REGISTRATION NUMBER: NCT02778399.
Keywords: BMD Endometriosis-associated pain GnRH antagonist linzagolix
Fav
Like
Download
Share
Export
Cite
6.3
Fertil Sterilfertility and sterility
Metadata
LocationUnited States
FromELSEVIER SCIENCE INC

No Data

© 2017 - 2020 Medicgo
Powered by some medical students