Clinical trial NCT02301897: 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
Official title: A Phase 2, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uterine Fibroids
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-26
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants in Amenorrhea at the End of Treatment Course 1
timeFrame: At the end of 18-weeks Treatment Course 1
Secondary outcomes:
measure: Percentage of Participants in Amenorrhea at the End of Treatment Course 2
timeFrame: At the end of 18-weeks Treatment Course 2
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
timeFrame: 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
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
timeFrame: 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
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
timeFrame: 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
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
timeFrame: 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
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
timeFrame: 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
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
timeFrame: 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
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
timeFrame: 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
measure: Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug
timeFrame: 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 Off-drug
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
facility: MomDoc Women's Health Research
state: Arizona
city: Fort Lauderdale
country: United States
facility: KO Clinical Research, LLC
state: Florida
city: Margate
country: United States
facility: South Florida Clinical Research Institute
state: Florida
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute, Inc.
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Sandy Springs
country: United States
facility: WR-Mount Vernon Clinical Research, LLC
state: Georgia
city: Metairie
country: United States
facility: Southern Clinical Research Associates, LLC
state: Louisiana
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Dallas
country: United States
facility: DCT-HCWC, LLC dba Discovery Clinical Trials
state: Texas
city: Houston
country: United States
facility: Advances in Health
state: Texas
city: Houston
country: United States
facility: The Women's Hospital of Texas Clinical Research Center
state: Texas
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
Study officials:
affiliation: Allergan
name: Anna Chan
role: STUDY_DIRECTOR
References: