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Neoplasms, Connective Tissue

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Uterine Diseases

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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Menstruation Disturbances

Elagolix

Placebo

ABBVIE INC.

The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.

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

A Phase 4 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Responders were defined as participants meeting the following 2 conditions:

* menstrual blood loss (MBL) volume \< 80 mL at the Final Month (defined as the last 28 days prior to and including the last dose day), and
* 50% or greater reduction in MBL volume from Baseline to the Final Month.

Participants whose primary reason for prematurely discontinuing study drug was "lack of efficacy," or "requires surgery or invasive intervention for treatment of uterine fibroids" were considered as non-responders. MBL was measured by the alkaline hematin method.

AbbVie

Elagolix 150 mg

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black or African American

Asian

Race/Ethnicity, Customized

Global Medical Services

Percentage of Participants Who Were Responders With Menstrual Blood Loss (MBL) Volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume From Baseline to the Final Month

Treatment Period

Post-Treatment Follow-Up Period

Reproductive Control Agents

All Drugs and Chemicals

Norethindrone

Norethindrone Acetate

Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Participants prescribed Oriahnn for management of heavy menstrual bleeding (HMB) due to uterine fibroids (UF).

Participants prescribed Oriahnn for management of HMB due to UF, with meaningful hair loss.

Uterine Fibroids (UF) are benign smooth muscle neoplasms of the uterus that affect women of reproductive age. UFs are one of the leading causes of hospitalizations for gynecological disorders and often lead to hysterectomy. In this study, women with heavy menstrual bleeding (HMB) due to UF who are being treated with Oriahnn will be followed to establish the incidence rate, time to onset, extent, pattern, and resolution of meaningful hair loss, as well as any racial differences.

Oriahnn is an approved drug for the management of HMB associated with UF. All study participants will receive Oriahnn as prescribed by their study doctor in accordance with approved local label. Study Participants will be followed for up 24 months (part 1). Approximately 1600 participants aged 18-50 years will be enrolled at 1 site in the United States.

Participants will receive oral Oriahnn as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for 24 months.

There is expected to be no additional burden for participants in this trial. Participants will complete questionnaires on a quarterly basis.

A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

A Prospective, Single-Arm, Descriptive Observational Study to Evaluate Changes in Hair in Women Exposed to Oriahnn® (Elagolix 300 mg BID With Estradiol 1 mg/Norethindrone Acetate 0.5 mg QD)

Meaningful hair loss is defined as patient-reported changes in thickness, fullness, or pattern of hair that results in less hair than normal or hair shedding that is increased from normal in the Hair Questionnaire.

Time from initiation of Oriahnn until patient-reported meaningful hair loss will be assessed.

Based on example description and images of alopecia subtypes, changes in patterns of hair loss are classified as primary pattern of hair loss.

Defined as a report that since the participant has reported hair loss, her hair loss has improved.

Resolution in hair loss is defined as a report that since the patient has reported hair loss, her hair has returned to normal.

Time from onset of meaningful hair loss until reported resolution.

Discontinuations of Oriahnn at or after reported hair loss will be calculated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women	NCT03886220	Uterine Fibroid...	Elagolix Placebo	18 Years - 51 Years	AbbVie
A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)	NCT06058728	Uterine Fibroid...		18 Years - 50 Years	AbbVie
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women	NCT03886220	Uterine Fibroid...	Elagolix Placebo	18 Years - 51 Years	AbbVie
A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)	NCT06058728	Uterine Fibroid...		18 Years - 50 Years	AbbVie

Spots Global Cancer Trial Database for heavy menstrual bleeding (hmb)