Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids

NCT01451424 | Completed Phase 2 Results

• 1 other identifier: ZPV-200
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally.

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Vaginal Bleeding

  Change from baseline in vaginal bleeding assessed at the end of treatment (12 or 16 weeks) using a Pictorial Blood Loss Assessment Chart (PBAC), which measures volume (mL) of blood loss over a 28-day period Less blood loss represents an improvement.

  12 or 16 weeks

Secondary Outcomes (5)

• Blood Levels of Proellex

  12 or 16 weeks

• Uterine Fibroid Size

  12 or 16 weeks

• Induction of Amenorrhea at End of Treatment

  End of treatment

• Endometrial Thickness

  12 or 16 weeks

• Change in Quality of Life

  12 or 16 weeks

Study Arms (5)

Proellex 12 mg PK group

EXPERIMENTAL

Subjects receiving 12 mg Proellex administered vaginally, and completing a PK arm consisting of 1 x 24 hr PK of Proellex, 14 days of daily Proellex trough measurements, and 1 x 24 hr PK of Proellex after 14 days of daily dosing. 12 mg PK subjects will continue with the protocol as written after the first 2 week period and will be treated for a total of 16 weeks.

Drug: Proellex

Proellex 12 mg per protocol

EXPERIMENTAL

Subjects receiving 12 mg Proellex daily, vaginally for 12 weeks

Drug: Proellex

Proellex 6 mg per protocol

EXPERIMENTAL

Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks

Drug: Proellex

Proellex 3 mg per protocol

EXPERIMENTAL

Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.

Drug: Proellex

24 mg Proellex

EXPERIMENTAL

24 mg vaginal Proellex daily for 16 weeks

Drug: Proellex

Interventions

Proellex DRUG

vaginal suppository, daily, for 12 weeks

Also known as: Telapristone acetate

24 mg Proellex; Proellex 12 mg PK group; Proellex 12 mg per protocol; Proellex 3 mg per protocol; Proellex 6 mg per protocol

Eligibility Criteria

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

You may qualify if:

• Healthy adult females between 18 and 47 years of age with uterine fibroids confirmed by ultrasound.
• Normal transvaginal ultrasound (other than for presence of fibroids)
• History of menstrual events occurring in regular cycles
• Agreement not to attempt to become pregnant
• Agreement to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours before each visit
• Ability to complete a daily subject diary
• Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study.
• Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
• A Body Mass Index (BMI) between 18 and 39 inclusive
• Is available for all treatment and follow-up visits.

You may not qualify if:

• Subject is a 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
• Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 6 month study period
• Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 1.5xULN AND total bilirubin exceeding 1.5xULN at screening and confirmed on repeat).
• Received an investigational drug in the 30 days prior to the screening for this study
• Women with a history of PCOS
• Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study.
• Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the preceding 6 months.
• Has an IUD in place
• Women currently using narcotics
• Women currently taking spironolactone
• Infectious disease screen is positive for HIV or Hepatitis A, B or C
• Clinically significant abnormal findings on screening examination 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 (2)

Cetero Research

Miami Gardens, Florida, 33169, United States

Location

Advances in Health

Houston, Texas, 77030, United States

Location

Related Links

• Repros Therapeutics Inc corporate website

MeSH Terms

Conditions

Leiomyoma

Interventions

telapristone acetate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jennifer Wike
• Organization: Repros Therapeutics Inc.

jwike@reprosrx.com

2817193402

Study Officials

• Ronald D Wiehle, PhD

  Repros Therapeutics Inc.

  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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 13, 2011
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: August 29, 2014
• Results First Posted: August 29, 2014

Record last verified: 2014-08

Locations

US (2)