Clinical trial · Interventional
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT01817530CI-TRIAL-00046068completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Heavy Uterine Bleeding | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.5 mg estradiol / 0.1 mg norethindrone acetate | Drug | — | UNRESOLVED |
| 1 mg estradiol / 0.5 mg norethindrone acetate | Drug | — | UNRESOLVED |
| E2/NETA placebo | Drug | — | UNRESOLVED |
| Elagolix | Drug | — | UNRESOLVED |
| Elagolix placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- PLACEBO_COMPARATOR
- label
- Cohort 1: Placebo
- description
- Placebo for elagolix and placebo for E2/NETA twice daily (BID)
- interventionNames
- Other: Elagolix placebo
- Drug: E2/NETA placebo
- type
- EXPERIMENTAL
- label
- Cohort 1: Elagolix 300 mg BID
- description
- Elagolix 300 mg BID alone
- interventionNames
- Drug: Elagolix
- Drug: E2/NETA placebo
- type
- EXPERIMENTAL
- label
- Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 51 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is pre-menopausal female 18 to 51 years of age at Screening. * Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound. * Subject has heavy uterine bleeding associated with uterine fibroids. Exclusion Criteria: * Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening. * Subject has a history of osteoporosis or other metabolic bone disease. * Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide. * Subject has a history of clinically significant condition(s) including but not limited to: \* Symptomatic Endometriosis \* Epilepsy or seizures \* Type 1 diabetes \* Chronic kidney disease \* Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
References
Publications (1)
- DERIVEDCarr BR, Stewart EA, Archer DF, Al-Hendy A, Bradley L, Watts NB, Diamond MP, Gao J, Owens CD, Chwalisz K, Duan WR, Soliman AM, Dufek MB, Simon JA. Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1252-1264. doi: 10.1097/AOG.0000000000002933. PMID 30303923