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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Doses ≥ 75 mg of linzagolix resulted in a significantly greater proportion of responders for overall pelvic pain, dysmenorrhea and non-menstrual pelvic pain after 12 and 24 weeks treatment.
“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]
The Secondary Efficacy Endpoints section reports significantly higher responder rates at week 12 for dysmenorrhea at 75, 100, and 200 mg, but for non-menstrual pelvic pain only at 75 and 100 mg; the 200 mg result was not significant (P=.297). It says responder rates were maintained or increased at week 24, but the Figure 1 caption states that no statistical testing was performed then because there was no placebo control. The claim overstates both the dose-wide significance and the significance at 24 weeks. (LLM, conf=0.92)
Experimental — accuracy not yet measuredWith linzagolix, serum estradiol was suppressed, QoL improved, and the rate of amenorrhea increased in a dose-dependent fashion.
“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 measuredWith linzagolix, 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.
“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]
Relugolix and linzagolix are two new oral GnRH antagonists in an advanced stage of clinical development for the management of pain associated with endometriosis.
“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]
A significant reduction in overall pelvic pain was already evident four to eight weeks after starting linzagolix treatment.
“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]
Percentages of women with a ≥30% reduction in overall pelvic pain at week 24 were 70.8%, 66.7% and 77.3% in the linzagolix 75 mg, 100 mg and 200 mg groups in phase II trials.
“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]
A similar pattern was observed in responder rates for dysmenorrhea and non-menstrual pelvic pain, with significant differences compared to placebo at 12 weeks with linzagolix 75 mg, 100 mg and 200 mg.
“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]
Percentages of women with a ≥30% reduction in overall pelvic pain at week 12 were 61.5%, 56.4% and 56.3% in the linzagolix 75 mg, 100 mg and 200 mg groups compared to 34.5% in the placebo group.
“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]
Relugolix and linzagolix have recently yielded very robust results in randomized, placebo-controlled clinical trials for the treatment of pain associated with endometriosis.
“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]
Based on EHP-30 questionnaire results, treatment with linzagolix resulted in enhanced quality of life.
“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]
Compared to placebo, there was a significant reduction in dyspareunia at 12 weeks with the linzagolix 200 mg dose, but not with 75 mg or 100 mg.
“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]
Significantly more women reported "much" or "very much" improvement on the PGIC scale by week 12 in the linzagolix 75 mg, 100 mg and 200 mg dose groups compared to the placebo group.
“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]
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 at week 12, with similar dose-related differences at week 24.
“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]
Most subjects taking linzagolix 200 mg showed a BMD decrease of >3% at 24 weeks, which would necessitate hormone add-back therapy for longer-term use.
“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]
Higher rates of hypoestrogenic symptoms were observed with linzagolix 200 mg, 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.
“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]
Pain and powerlessness domains of the EHP-30 were significantly transformed with linzagolix 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.
“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]
Percentages of women experiencing a reduction of ≥30% in both dysmenorrhea and non-menstrual pelvic pain at 12 weeks were 68.2% and 58.5% in the linzagolix 75 mg group, 68.6% and 61.5% in the 100 mg group, and 78.9% and 47.7% in the 200 mg group.
“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]
Response rates for overall pelvic pain, dysmenorrhea and non-menstrual pelvic pain were maintained or increased after 24 weeks of linzagolix treatment.
“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]
With linzagolix 75 mg and 100 mg, there was dose-dependent partial suppression of serum E2 to between 20 and 60 pg/mL.
“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]
Mean percentage (95% CI) BMD changes for the lumbar spine from baseline to week 24 in the linzagolix 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.
“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]
These results suggest that although partial suppression of E2 has a significant impact on important aspects of general well-being, full suppression with linzagolix 200 mg has a more constant effect across more aspects of quality of life affected by endometriosis.
“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]
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 linzagolix 75 mg group, 82.1% and 64.1% in the 100 mg group, and 84.1% and 72.7% in the 200 mg group.
“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]
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.
“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]
At week 12, estimated amenorrhea rates were 4.3% in the placebo group and 36.3%, 55.8% and 80.9% in the linzagolix 75 mg, 100 mg and 200 mg dose groups.
“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]
With linzagolix 200 mg, serum E2 was rapidly and fully suppressed to 11 pg/mL by week 4, and this was maintained (range 11-16 pg/mL) up to week 24.
“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]
There was a dose-dependent increase in the rate of amenorrhea from weeks 4 to 24 with linzagolix.
“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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- 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 › Public Health, Environmental and Occupational Health › 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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