A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

NCT02301897 | Completed Phase 2 Results DMC

• 1 other identifier: ZPU-203
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 16

Brief Summary

The primary objective of this study is to determine the safety and efficacy of two oral doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants in Amenorrhea at the End of Treatment Course 1

  Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.

  At the end of 18-weeks Treatment Course 1

Secondary Outcomes (13)

• Percentage of Participants in Amenorrhea at the End of Treatment Course 2

  At the end of 18-weeks Treatment Course 2

• Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit

  Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU Visit

• Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit

  Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU Visit

• Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit

  Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit

• Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit

  Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).

Drug: Placebo

Telapristone Acetate 6 mg

EXPERIMENTAL

Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.

Drug: Telapristone Acetate

Telapristone Acetate 12 mg

EXPERIMENTAL

Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.

Drug: Telapristone Acetate

Interventions

Telapristone Acetate DRUG

Telapristone acetate, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

Also known as: Proellex®

Telapristone Acetate 12 mg; Telapristone Acetate 6 mg

Placebo DRUG

Matching placebo, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is a pre-menopausal female, between 18 and 47 years
• Participant has a history of at least 3 regular menstrual cycles in which menorrhagia (heavy bleeding) is due to uterine fibroids
• Confirmed uterine fibroid(s) at screening
• Visit 1 historical pictorial blood loss assessment chart of \>120 milliliters (mL) of blood loss, to ensure participants have a menstrual blood loss of at least 80 mL by Alkaline Hematin Assay (during the baseline assessment period).
• A Body Mass Index (BMI) between 18 and 45 inclusive

You may not qualify if:

• Participant is pregnant or lactating or is attempting or expecting to become pregnant during the entire study period
• Received an investigational drug in the 30 days prior to the screening for this study
• Has an intrauterine device in place
• Observation or history of abnormal endometrial biopsy including the presence of endometrial intraepithelial neoplasia
• Participants with abnormally high liver enzymes or liver disease

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (16)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Unknown Facility

Phoenix, Arizona, 85015, United States

Location

MomDoc Women's Health Research

Scottsdale, Arizona, 85251, United States

Location

KO Clinical Research, LLC

Fort Lauderdale, Florida, 33316, United States

Location

South Florida Clinical Research Institute

Margate, Florida, 33063, United States

Location

Atlanta Women's Research Institute, Inc.

Atlanta, Georgia, 30342, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

Southern Clinical Research Associates, LLC

Metairie, Louisiana, 70001, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

The Jackson Clinic, PA

Jackson, Tennessee, 38305, United States

Location

Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

DCT-HCWC, LLC dba Discovery Clinical Trials

Dallas, Texas, 75231, United States

Location

Advances in Health

Houston, Texas, 77030, United States

Location

The Women's Hospital of Texas Clinical Research Center

Houston, Texas, 77054, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

telapristone acetate; Sugars

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Anna Chan

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: March 16, 2015
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: June 19, 2019
• Results First Posted: June 19, 2019

Record last verified: 2019-05

Locations

US (16)