Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
This study has been completed.
Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01817530
First received: March 21, 2013
Last updated: June 15, 2016
Last verified: June 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heavy Uterine Bleeding Uterine Fibroids |
Other: Placebo Drug: Elagolix Drug: Estradiol/norethindrone acetate, E2/NETA Drug: Estradiol/norethindrone acetate, E2/NETA Dose 2 Drug: Estradiol/norethindrone acetate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Estradiol
Norethindrone acetate
Norethindrone
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Change in Menstrual Blood Loss [ Time Frame: From Baseline to Month 6 ] [ Designated as safety issue: No ]Change in menstrual blood loss measured by alkaline hematin method
Secondary Outcome Measures:
- Change in Physical Examination [ Time Frame: From Day 1 through 6 Months Post-dosing ] [ Designated as safety issue: Yes ]
- Change from Baseline in the number of subjects with adverse events [ Time Frame: From Day 1 through 6 months post dose ] [ Designated as safety issue: Yes ]
- Change in Bone Mineral Density (BMD) [ Time Frame: From Day 1 through Month 6 ] [ Designated as safety issue: Yes ]
- Change in Endometrial Assessment [ Time Frame: From 3 months prior to dosing up to 6 Months Post-dosing ] [ Designated as safety issue: Yes ]Change in endometrial thickness
- Change in Clinical Laboratory Tests [ Time Frame: From Day 1 up to 3 Months Post-dosing ] [ Designated as safety issue: Yes ]Chemistry, Urinalysis, complete blood count, bone biomarkers, lipid profile
- Percentage of Subjects with reduction in Menstrual Blood Loss [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]
- Percentage Subjects with amenorrhea [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]
- Percentage of Subjects with No Bleeding (spotting allowed) [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]
- Number of Bleeding Days [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]
- Percent Change from baseline in bleeding scores per bleeding diary [ Time Frame: From Day 1 to Month 6 ] [ Designated as safety issue: No ]
- Percent Change in Uterine Volume [ Time Frame: From Day 1 to Month 6 ] [ Designated as safety issue: No ]
- Percent Change in Fibroid Volume [ Time Frame: From Day 1 to Month 6 ] [ Designated as safety issue: No ]
- Percent change in hemoglobin concentration [ Time Frame: From Day 1 through Month 6 ] [ Designated as safety issue: No ]
- Change in bone mineral density [ Time Frame: From 3 months prior to dosing through 6 months post-dosing ] [ Designated as safety issue: Yes ]
- Change in percentage of subjects with hypoestrogenic effects [ Time Frame: From Day 1 to Month 6 ] [ Designated as safety issue: Yes ]
- Proportion reporting treatment-emergent adverse events [ Time Frame: Up to 6 months post-dosing ] [ Designated as safety issue: Yes ]
- Change from Baseline in the percent of subjects with adverse events [ Time Frame: From Day 1 through 6 months post dose ] [ Designated as safety issue: Yes ]
| Enrollment: | 571 |
| Study Start Date: | January 2013 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo 1
Placebo
|
Other: Placebo
Placebo for 6 Month Treatment Period
|
|
Experimental: Elagolix Dose 1
Elagolix Dose 1
|
Drug: Elagolix
Elagolix Dose 1 for 6 Month treatment Period
Other Name: ABT-620
|
|
Experimental: Elagolix Dose 1 plus E2/NETA Dose 1
Elagolix Dose 1 plus E2/NETA (estradiol/norethindrone acetate) Dose 1
|
Drug: Elagolix
Elagolix Dose 1 for 6 Month treatment Period
Other Name: ABT-620
Drug: Estradiol/norethindrone acetate, E2/NETA
E2/NETA Dose 1
|
|
Experimental: Elagolix Dose 1 plus E2/NETA Dose 2
Elagolix Dose 1 plus E2/NETA (estradiol/norethindrone acetate) Dose 2
|
Drug: Elagolix
Elagolix Dose 1 for 6 Month treatment Period
Other Name: ABT-620
Drug: Estradiol/norethindrone acetate, E2/NETA Dose 2
E2/NETA Dose 2
|
|
Placebo Comparator: Placebo 2
Placebo
|
Other: Placebo
Placebo for 6 Month Treatment Period
|
|
Experimental: Elagolix Dose 2
Ealgolix Dose 2
|
Drug: Elagolix
Elagolix Dose 2 for 6 Month Treatment Period
Other Name: ABT-620
|
|
Experimental: Elagolix Dose 2 plus E2/NETA Dose 1
Elagolix Dose 2 plus E2/NETA (estradiol/norethindrone acetate) Dose 1
|
Drug: Estradiol/norethindrone acetate, E2/NETA
E2/NETA Dose 1
|
|
Experimental: Elagolix Dose 2 plus E2/NETA Dose 2
Elagolix Dose 2 plus E2/NETA (estradiol/norethindrone acetate) Dose 2
|
Drug: Estradiol/norethindrone acetate
E2/NETA Dose 2
|
Eligibility| Ages Eligible for Study: | 18 Years to 51 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01817530
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01817530
Show 100 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | Charlotte Owens, MD | AbbVie |
More Information
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT01817530 History of Changes |
| Other Study ID Numbers: | M12-813 2013-000082-37 |
| Study First Received: | March 21, 2013 |
| Last Updated: | June 15, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AbbVie:
|
Uterine Fibroids Leiomyomata Elagolix Menorrhagia |
Elagolix sodium Heavy Uterine Bleeding ABT-620 |
Additional relevant MeSH terms:
|
Hemorrhage Leiomyoma Myofibroma Uterine Hemorrhage Menorrhagia Pathologic Processes Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases Uterine Diseases Genital Diseases, Female Menstruation Disturbances |
Estradiol Polyestradiol phosphate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estradiol valerate Norethindrone Norethindrone acetate Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Synthetic |
ClinicalTrials.gov processed this record on September 23, 2016