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Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis

NCT00437658 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2018-10-12

Study results available
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Summary

This study is designed to assess the effects of elagolix versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC; also known as depo-provera) on bone mineral density (BMD) during treatment for 24 weeks with a subsequent 24-week post-treatment period.

Conditions

  • Endometriosis

Interventions

DRUG

Elagolix

Provided as tablets for oral administration

DRUG

Subcutaneous depot medroxyprogesterone acetate (DMPA-SC)

Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe.

DRUG

Placebo to Elagolix

Matching placebo tablets for oral administration

DRUG

Placebo to DMPA-SC

Matching placebo for subcutaneous injection in a pre-filled syringe

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-11
Primary Completion
2008-11-24
Completion
2008-11-24
FDA Drug
Yes

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00437658 on ClinicalTrials.gov