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OpenTrials
Completed

NCT Number: NCT01817530

Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

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.

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Key information

Conditions

Heavy Uterine Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Leiomyoma Menorrhagia Menstruation Disturbances Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Fibroids Uterine Hemorrhage

Age range

18 year–51 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elagolix placebo

Other

oral coated tablet

Elagolix

Drug

oral coated tablet

Other names: ABT-620

0.5 mg estradiol / 0.1 mg norethindrone acetate

Drug

oral hard capsule

Other names: Activelle, Activella, low dose (LD) E2/NETA

1 mg estradiol / 0.5 mg norethindrone acetate

Drug

oral hard capsule

Other names: Activelle, Activella, standard dose (SD) E2/NETA

E2/NETA placebo

Drug

oral hard capsule

Primary outcomes

  1. 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

    Time frame: Baseline, Final Month (last 28 days of treatment)

    The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of < 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.

Secondary outcomes

  1. 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

    Time frame: Baseline, second last 28 days of treatment (last 56 to 29 days of treatment)

    The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 56 to 29 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.

  2. 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

    Time frame: Baseline, third last 28 days of treatment (last 84 to 57 days of treatment)

    The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 84 to 57 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.

  3. Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month

    Time frame: Final Month (last 28 days of treatment)

    Percentage of participants who achieved an MBL volume of < 80 mL at the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.

  4. Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month

    Time frame: Baseline, Final Month (last 28 days of treatment)

    Percentage of participants with a >= 50% reduction from baseline in MBL to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.

  5. Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment

    Time frame: Last 56 days of treatment (after 10 days from first dose date)

    Amenorrhea is defined as having 0 days of bleeding or spotting based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding or spotting, based on imputed electronic diary data during the last 56 days of treatment. Participants needed to have at least 66 days on treatment.

  6. Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment

    Time frame: Last 56 days of treatment (after 10 days from first dose date)

    Suppression of bleeding is defined as having 0 days of bleeding based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding (spotting is allowed) based on imputed electronic diary data during the last 56 days of treatment.

  7. Mean Change in the Number of Bleeding Days From Baseline to Month 6

    Time frame: Baseline, Month 6

    The number of days with any bleeding including spotting was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.

  8. Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6

    Time frame: Baseline, Month 6

    The number of days with heavy bleeding (either heavy or very heavy/gushing bleeding) was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.

  9. Change in Bleeding Severity Scores From Baseline at the Final Month

    Time frame: Baseline, Final Month (last 28 days of treatment)

    The average bleeding score was calculated for each 28-day interval starting on Day 29 using data collected on daily bleeding diary using the Mansfield-Voda-Jorgenson (MVJ) Menstrual Bleeding Scale (1=spotting, 2 = very light bleeding, 3 = light bleeding, 4 = moderate bleeding, 5 = heavy bleeding, 6 = very heavy/gushing bleeding). Baseline is defined as the last 28 days prior to the first day of study drug.

  10. Mean Change in Hemoglobin Concentration From Baseline to Final Visit

    Time frame: Baseline, Final Visit during treatment period (Month 6 or early termination)

    Baseline is defined as the last measurement prior to the first dose of study drug.

  11. Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit

    Time frame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)

    Volume of the total fibroid volume (3 largest fibroids), as measured by transvaginal ultrasound, or transabdominal ultrasound.

  12. Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit

    Time frame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)

    Volume of the largest fibroid (primary fibroid), as measured by transvaginal ultrasound, or transabdominal ultrasound.

  13. Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit

    Time frame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)

    Uterine volume, as measured by transvaginal ultrasound or transabdominal ultrasound.

  14. Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit

    Time frame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)

    Total fibroid volume (3 largest fibroids) was measured by transvaginal ultrasound, or transabdominal ultrasound.

  15. Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit

    Time frame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)

    Volume of the largest fibroid (primary fibroid) was measured by transvaginal ultrasound or transabdominal ultrasound.

  16. Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit

    Time frame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)

    Uterine volume was measured by transvaginal ultrasound or transabdominal ultrasound.

  17. Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire

    Time frame: 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

    The NBUFSQ (8 items) is a brief patient-reported daily diary that assesses non-bleeding symptoms experienced by women with uterine fibroids. It includes 6 items, asking women to rate their symptoms (abdominal/pelvic pain, pressure, and cramping, back pain, bloating, and urinary problems) in the past 24 hours using an 11-point numeric response scale that ranges from 0 (i.e., no symptom) to 10 (i.e., worst possible symptom) and 2 items to address urinary frequency during the daytime and at night. Data presented in the sum of scores to the 6 symptom questions, ranging from 0 (no symptoms) to 60 (worst possible symptoms). Baseline is defined as the last 28 days prior to the first day of study drug. Final Month is defined as the last 28 days prior to and including the last dose date of study drug.

  18. Percentage of Participants Who Successfully Avoided Surgical or Invasive Procedures for Uterine Fibroids

    Time frame: Month 6

    The percentage of participants who successfully avoided surgical or invasive procedures for Uterine Fibroids was assessed.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 25, 2013
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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