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Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone–antagonist: a randomized clinical trial
Open accessAbstract
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.
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In the citing paper
“Doses ≥ 75 mg resulted in a significantly greater proportion of responders for overall pelvic pain, dysmenorrhea and non-menstrual pelvic pain after 12 and 24 weeks treatment.”
From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [181]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“Serum estradiol was suppressed, QoL improved, and the rate of amenorrhea increased in a dose-dependent fashion.”
From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [181]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“Also mean BMD loss (spine) increased in a dose-dependent manner and was < 1% at 24 weeks at doses of 50 and 75 mg and up to 2.6% for 200 mg.”
From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [181]
The cited source says what the claim attributes to it.
In the citing paper
“Relugolix and linzagolix are the two new oral GnRH antagonists, in an advanced stage of clinical development for the management of pain associated with endometriosis [180, 181].”
From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [181]
In the citing paper
“A significant reduction in overall pelvic pain was already evident four to eight weeks after starting treatment.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Percentages of women with a ≥30% reduction in overall pelvic pain at week 24 were 70.8%, 66.7% and 77.3% in the 75 mg, 100 mg and 200 mg groups, respectively, in phase II trials (Table 1).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“A similar pattern was observed in responder rates for dysmenorrhea and non-menstrual pelvic pain, with significant differences observed compared to the placebo at 12 weeks with doses of 75 mg, 100 mg and 200 mg.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Percentages of women with a ≥30% reduction in overall pelvic pain (primary efficacy endpoint) at week 12 were respectively 61.5%, 56.4% and 56.3% in the 75 mg, 100 mg and 200 mg groups compared to 34.5% in the placebo group [105].”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Two more oral GnRH antagonists, namely, relugolix (TAK385) [104] and linzagolix (OBE-2109) [105], have recently yielded very robust results in randomized, placebo-controlled clinical trials for the treatment of pain associated with endometriosis, and will be discussed in detail further.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Based on EHP-30 questionnaire results, treatment with linzagolix resulted in enhanced quality of life.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Compared to the placebo, there was a significant reduction in dyspareunia at 12 weeks with the 200 mg dose, but not with 75 mg or 100 mg.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Significantly more women reported “much” or “very much” improvement on the PGIC scale by week 12 in the 75 mg, 100 mg and 200 mg dose groups compared to the placebo group.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Hot flushes were more frequent at higher doses of linzagolix, namely, 19.3%, 26.9% and 42.1% with 75 mg, 100 mg and 200 mg, respectively, at week 12, with similar dose-related differences at week 24 (Table 1) [105].”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Most subjects taking the 200 mg dose showed a BMD decrease of >3% at 24 weeks, which would necessitate hormone add-back therapy for longer-term use.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“However, higher rates of hypoestrogenic symptoms were observed, including BMD loss of ≥3% after 24 weeks, indicating that this once-daily dose will require hormone add-back therapy if used for longer than six months [105].”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Concerning the different parts of the EHP-30 questionnaire, pain and powerlessness domains were significantly transformed with 75 mg, 100 mg and 200 mg doses, whereas for other domains linked to emotional well-being, social support and self-image, there was a consistent significant difference only in the 200 mg dose group.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Percentages of women experiencing a reduction of ≥30% in both dysmenorrhea and non-menstrual pelvic pain at 12 weeks were respectively 68.2% and 58.5% in the 75 mg group, 68.6% and 61.5% in the 100 mg group and 78.9% and 47.7% in the 200 mg group.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Response rates for overall pelvic pain, dysmenorrhea and non-menstrual pelvic pain were maintained or increased after 24 weeks of treatment.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“With the 75 mg and 100 mg doses of linzagolix, there was dose-dependent partial suppression of serum E2 to between 20 and 60 pg/mL.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Mean percentage (95% CI) BMD changes for the lumbar spine from baseline to week 24 in the 75 mg, 100 mg and 200 mg dose groups were −0.80% (−1.57, −0.03), −1.37% (−2.14, −0.59) and −2.60% (−3.56, −1.65), respectively.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“These results suggest that although partial suppression of E2 has a significant impact on important aspects of general well-being, full suppression with 200 mg has a more constant effect across more aspects of quality of life affected by endometriosis [105].”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Percentages of women experiencing a reduction of >30% in both dysmenorrhea and non-menstrual pelvic pain at week 24 were 58.3% and 72.9% in the 75 mg group, 82.1% and 64.1% in the 100 mg group and 84.1% and 72.7% in the 200 mg group.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“In conclusion, consistent with full suppression of serum E2 to postmenopausal levels, once-daily linzagolix 200 mg provided an additional significant impact on dyspareunia and some aspects of quality of life.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“At week 12, estimated amenorrhea rates were 4.3% in the placebo group and 36.3%, 55.8% and 80.9% in the 75 mg, 100 mg and 200 mg dose groups, respectively.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“Concerning serum E2, there was rapid and full suppression to 11 pg/mL in the 200 mg dose group by week 4, which was maintained (range 11–16 pg/mL) up to week 24 (Figure 5).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
In the citing paper
“There was a dose-dependent increase in the rate of amenorrhea from weeks 4 to 24.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [105]
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Citations
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Metadata
- Authors
- Donnez, J., Taylor, H. S., Taylor, R. N., Akin, M. D., Tatarchuk, T. F., Wilk, K., Gotteland, J.-P., Lecomte, V., & Bestel, E.
- Affiliations
- UCLouvain (BE)
- Yale University (US)
- University of Utah (US)
- Texas Fertility Center (US)
- ObsEva (Switzerland) (CH)
- Corresponding author
- Bestel, Elke
- Venue
- Fertility and Sterility
- Publisher
- Elsevier BV
- Published
- 2020-07
- Volume
- 114
- Issue
- 1
- Pages
- 44-55
- ISSN
- 0015-0282 (ISSN-L)
- OpenAlex
- W3033596374
- Cited by
- 124
- References
- 32
- Citations by year
- 2026: 22 · 2025: 17 · 2024: 19 · 2023: 21 · 2022: 21 · 2021: 19 · 2020: 5
- FWCI
- 14.53
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Fertility and Sterility (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Menstrual Health and Disorders
- Health Sciences › Medicine › Obstetrics and Gynecology › Ectopic Pregnancy Diagnosis and Management
- Keywords
- linzagolix, endometriosis-associated pain, dysmenorrhea, non-menstrual pelvic pain, estradiol suppression, amenorrhea, bone mineral loss, quality of life, dose-response relationship
- MeSH terms
- Administration, Oral, Adolescent, Adult, Carboxylic Acids, Dose-Response Relationship, Drug, Double-Blind Method, Endometriosis, Female, Hormone Antagonists, Humans, Gonadotropin-Releasing Hormone, Middle Aged, Organic Chemicals, Pyrimidines, Uterine Diseases, Treatment Outcome, Pelvic Pain, Young Adult, Chronic Pain
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