Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

AbbVie

Status and phase: Completed; Phase 2

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Elagolix; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03951077

M16-837

Details and patient eligibility

About

This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).

Full description

This is a phase 2, multicenter, double-blind (sponsor-unblinded), randomized, placebo-controlled study to assess the safety and efficacy of elagolix in women with PCOS. PCOS is one of the most common hormonal disorders in women of reproductive age, yet few treatment options are available. This study will help determine if elagolix can impact disordered hormonal dynamics in women with PCOS and at what dosage.

Enrollment: 118 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with clinical diagnosis of PCOS.
• Participants with a body mass index (BMI) of 18.5 to 38 kg/m^2 at time of Screening.

Exclusion criteria

• Participants with newly diagnosed medical condition requiring intervention that has not been stabilized at least 30 days prior to Baseline.
• Participants with a significant medical condition that require intervention during the course of study participation (such as anticipated major elective surgery).
• Participants with an unstable medical condition (including, but not limited to, uncontrolled hypertension, epilepsy requiring anti-epileptic medicine, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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118 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo taken orally twice a day (BID)

Treatment:

Drug: Placebo

Elagolix 25 mg BID

Experimental group

Description:

Elagolix 25 mg taken orally BID plus placebo

Treatment:

Drug: Placebo

Drug: Elagolix

Elagolix 50 mg Once Daily (QD)

Experimental group

Description:

Elagolix 50 mg taken orally QD plus placebo

Treatment:

Drug: Placebo

Drug: Elagolix

Elagolix 75 mg BID

Experimental group

Description:

Elagolix 75 mg taken orally BID plus placebo

Treatment:

Drug: Placebo

Drug: Elagolix

Elagolix 150 mg QD

Experimental group

Description:

Elagolix 150 mg taken orally QD plus placebo

Treatment:

Drug: Placebo

Drug: Elagolix

Elagolix 300 mg QD

Experimental group

Description:

Elagolix 300 mg taken orally QD plus placebo

Treatment:

Drug: Placebo

Drug: Elagolix

Sponsor of this trial

Lead Sponsor

AbbVie