Clinical trial NCT02323646: Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of 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 Vaginally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uterine Fibroids
Keywords: uterine fibroids
leiomyoma
fibroid tumor
fibroma
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-23
Enrollment: 42
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 vaginal 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:

* Adult females between 18 and 47 years.
* Have a history of at least 3 regular menstrual cycles in which menorrhagia is due to uterine fibroids.
* Must have uterine fibroids.
* Agreement not to attempt to become pregnant during the trial.
* Agreement to use only sanitary pads provided throughout the course of the study, tampon use is prohibited .
* Ability to complete a daily Participant diary and study procedures in compliance with the protocol.
* Have a negative pregnancy test at the Screening and Baseline visits, and subsequent study visits.
* A Body Mass Index (BMI) between 18 and 45 inclusive.
* Menstrual blood loss \> 80 milliliters (mL) by alkaline hematin assay.

Exclusion Criteria:

* Post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy.
* 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.
* History of Polycystic Ovarian Syndrome (PCOS).
* Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, Dihydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to screening and during the study.
* Use of oral contraceptives in the preceding 30 days. Use of Depo-Provera® in the preceding 10 months.
* Use of Gonadotropin Releasing Hormone (GnRHas) (e.g. Lupron Depot) within 3 months of the first dose of study drug (Lupron Depot must have a wash-out period of 3 months).
* Has an Intra Uterine device (IUD) in place.
* Known or suspected carcinoma of the breast or reproductive organs.
* Recent history (within past 6 months) of alcoholism or drug abuse.
* Clinically significant abnormal findings on screening examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study.

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: Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2
timeFrame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2
measure: Percentage Change in Transformed Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit
timeFrame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit
timeFrame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit
timeFrame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit
timeFrame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit
timeFrame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit
timeFrame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit
timeFrame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit
timeFrame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
measure: Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit
timeFrame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
measure: Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2
timeFrame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
state: Florida
city: Sandy Springs
country: United States
state: Georgia
city: Metairie
country: United States
state: Louisiana
city: Saginaw
country: United States
state: Michigan
city: Raleigh
country: United States
state: North Carolina
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Allergan
name: Anna Chan
role: STUDY_DIRECTOR
References: