Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids

NCT02323646 | Completed Phase 2 Results

• 1 other identifier: ZPV-201
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 8

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.

Conditions

Uterine Fibroids

Keywords

uterine fibroids; leiomyoma; fibroid tumor; fibroma

Outcome Measures

Primary Outcomes (1)

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

  Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score \>1. Participants were provided with a daily diary and Pictorial Blood Loss Assessment Chart (PBAC) to record information about the menstrual blood loss (MBL). Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding.

  At the end of 18-weeks Treatment Course 1

Secondary Outcomes (12)

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

  At the end of 18-weeks Treatment Course 2

• Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2

  Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2

• 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

  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

• 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

  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

• 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

  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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Telapristone Acetate 6 mg

EXPERIMENTAL

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

Drug: Telapristone Acetate

Telapristone Acetate 12 mg

EXPERIMENTAL

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

Drug: Telapristone Acetate

Interventions

Placebo DRUG

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

Placebo

Telapristone Acetate DRUG

Telapristone acetate, vaginally, 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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (8)

Unknown Facility

Fort Lauderdale, Florida, 33316, United States

Location

Unknown Facility

Sandy Springs, Georgia, 30328, United States

Location

Unknown Facility

Metairie, Louisiana, 70001, United States

Location

Unknown Facility

Saginaw, Michigan, 48604, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Houston, Texas, 77054, United States

Location

Unknown Facility

Richmond, Virginia, 23235-4759, United States

Location

MeSH Terms

Conditions

Leiomyoma; Fibroma

Interventions

telapristone acetate

Condition Hierarchy (Ancestors)

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

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: December 18, 2014
• First Posted: December 23, 2014
• Study Start: February 12, 2015
• Primary Completion: April 6, 2017
• Study Completion: April 6, 2017
• Last Updated: June 25, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-06

Locations

US (8)