Clinical trial NCT01817530: Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Official title: A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heavy Uterine Bleeding
Uterine Fibroids
Keywords: Uterine Fibroids
Leiomyomata
Elagolix
Menorrhagia
Elagolix sodium
Heavy Uterine Bleeding
ABT-620
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-03-25
Enrollment: 571
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
timeFrame: Baseline, Final Month (last 28 days of treatment)
Secondary outcomes:
measure: Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment
timeFrame: Baseline, second last 28 days of treatment (last 56 to 29 days of treatment)
measure: Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment
timeFrame: Baseline, third last 28 days of treatment (last 84 to 57 days of treatment)
measure: Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month
timeFrame: Final Month (last 28 days of treatment)
measure: Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
timeFrame: Baseline, Final Month (last 28 days of treatment)
measure: Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment
timeFrame: Last 56 days of treatment (after 10 days from first dose date)
measure: Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment
timeFrame: Last 56 days of treatment (after 10 days from first dose date)
measure: Mean Change in the Number of Bleeding Days From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: Change in Bleeding Severity Scores From Baseline at the Final Month
timeFrame: Baseline, Final Month (last 28 days of treatment)
measure: Mean Change in Hemoglobin Concentration From Baseline to Final Visit
timeFrame: Baseline, Final Visit during treatment period (Month 6 or early termination)
measure: Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
timeFrame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
measure: Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
timeFrame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
measure: Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
timeFrame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
measure: Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
timeFrame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
measure: Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
timeFrame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
measure: Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
timeFrame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
measure: Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
timeFrame: Baseline, Days 1-28, Days 29-56, Days 57-84, Days 85-112, Days 113-140, Days 141-168, Final Month of treatment, Post-treatment (PT) Days 1-28, PT Days 29-56, PT Days 57-84, PT Days 85-112, PT Days 113-140, PT Days 141-168
measure: Percentage of Participants Who Successfully Avoided Surgical or Invasive Procedures for Uterine Fibroids
timeFrame: Month 6
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Charlotte Owens, MD
role: STUDY_DIRECTOR
References:
citation: Carr 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.