Clinical trial NCT02811159: An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Official title: An Open-Label Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Uterine Fibroids
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 \[NCT02323646\] or ZPU-203 \[NCT02301897\] and meet eligibility criteria.

Detailed description: This study will be for participants who had completed either ZPV-201 or ZPU-203.

Eligibility criteria: Inclusion Criteria:

* Completed either study ZPV-201 \[NCT02323646\] or ZPU-203 \[NCT02301897\]
* Agreement not to attempt to become pregnant during the trial
* Agreement to use alcohol in moderation and record the daily consumption (note: elevated liver enzymes may result in discontinuation from the study)
* Ability to complete a daily subject diary and study procedures in compliance with the protocol
* Women of child-bearing potential must be willing to use double-barrier contraception during the study and off-drug intervals. Acceptable double-barrier methods are: male condom with spermicide; male condom with diaphragm; diaphragm containing spermicide plus additional intra-vaginal spermicide
* Has a negative pregnancy test at Visit 1
* Subject is available for all treatment and follow-up visits

Exclusion Criteria:

* Subject had a significant decrease in bone mineral density while participating in ZPV-201 or ZPU-203 (total hip or spine measurement decreased by 5% or more)
* Subject has undergone hysterectomy and/or bilateral oophorectomy since enrollment in ZPV-201 or ZPU-203
* Subject is pregnant or lactating or is attempting or expecting to become pregnant during the entire study period
* Subjects with abnormally high liver enzymes or liver disease. \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 x upper limit of normal (ULN) and total bilirubin exceeding 1.5 x ULN at Visit 1 and confirmed on repeat\].
* Subject has a hemoglobin of \<7.5 grams per deciliter (g/dL) at Visit 1
* Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, dehydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to Visit 1
* Use of oral contraceptives in the 30 days preceding screening. Use of Depo-Provera® in the preceding 10 months
* Use of Gonadotrophin releasing hormone agonist (GnRHas) (e.g. Lupron Depot) within 3 months prior to screening (Lupron Depot must have a wash-out period of 3 months prior to screening)
* Has an intra-uterine device (IUD) in place
* Current cervical dysplasia classified as Atypical Squamous Cells of Undetermined Significance (ASCUS) associated with high-risk human papilloma virus (HPV)
* Current diagnosis of Low/High Grade Squamous Intraepithelial Lesion (LGSIL or HGSIL), endometrial polyps or hyperplasia
* Observation or history of abnormal endometrial biopsy including the presence of endometrial intraepithelial neoplasia (EIN)
* Recent history (within past 6 months) of alcoholism or drug abuse
* Endometrial stripe ≥18 mm in thickness at Visit 1 (subject may be enrolled with sponsor approval)
* Subject is currently taking cimetidine or spironolactone or has taken them in the last 30 days
* Clinically significant abnormal findings on Visit 1 examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the subject's ability to comply with the study instructions or endanger the subject if she took part in the study.

Primary outcomes:
measure: Percentage of Participants in Amenorrhea
timeFrame: At the end of 18 weeks Treatment Course 1
measure: Percentage Change From Baseline in Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score
timeFrame: Baseline to the end of 18-weeks Treatment Course 1
measure: Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 1
timeFrame: Baseline to the end of 18-weeks Treatment Course 1
measure: Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 2
timeFrame: Baseline to the end of 18-weeks Treatment Course 1
measure: Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 3
timeFrame: Baseline to the end of 18-weeks Treatment Course 1
measure: Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 4
timeFrame: Baseline to the end of 18-weeks Treatment Course 1
measure: Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 5
timeFrame: Baseline to the end of 18-weeks Treatment Course 1
measure: Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 6
timeFrame: Baseline to the end of 18-weeks Treatment Course 1
measure: Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 7
timeFrame: Baseline to the end of 18-weeks Treatment Course 1
measure: Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 8
timeFrame: Baseline to the end of 18-weeks Treatment Course 1
measure: Change From Baseline in Pictorial Blood Loss Assessment Chart (PBAC) Score
timeFrame: Baseline to the end of 18-weeks Treatment Course 1
measure: Percentage Change From Baseline in Total Uterine Fibroid Volume
timeFrame: Baseline to the end of 18-weeks Treatment Course 1
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: KO Clinical Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute, Inc.
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: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
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: