Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02691494 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 378
- Enrollment target
NCT02691494: Completed Phase 3 study, sponsored by AbbVie.
NCT02691494 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 378 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02691494, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 378 participants
- Enrollment target
Study Summary
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Primary Outcome
Percentage of responders, defined as participants who met the following conditions: * Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the Reference Day, which is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date), and * ≥ 50% reduction in MBL volume from Baselin
Interventions
- DRUG Elagolix
- DRUG Placebo for Estradiol/Norethindrone Acetate
- DRUG Estradiol/Norethindrone Acetate
- DRUG Placebo for Elagolix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 378 participants |
| Start Date | 2016-02-03 |
| Est. Completion | 2019-01-23 |
| Phase | Phase 3 |
What the finished NCT02691494 record still lists
NCT02691494 is an interventional study that assigns participants to a tested intervention. The registered 378 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 4 interventions - of which Elagolix is the first listed.
NCT02691494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02691494 about?
NCT02691494 is a clinical study titled "Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)". This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
What is the current status of trial NCT02691494?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 378 participants. The study started on 2016-02-03. Estimated completion is 2019-01-23.
What interventions are being tested in trial NCT02691494?
The interventions under investigation include: Elagolix (DRUG), Placebo for Estradiol/Norethindrone Acetate (DRUG), Estradiol/Norethindrone Acetate (DRUG), Placebo for Elagolix (DRUG).
Who is sponsoring clinical trial NCT02691494?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02691494's enrollment target sits among peer trials
378 988th of 2000 higher than 1,013 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04254185 · 378 participants · NA
Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
- NCT06616584 · 378 participants · Phase 2
Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)
- NCT07024784 · 377 participants · Phase 2
A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies
- NCT04560673 · 380 participants · Phase 2
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI