A Phase 2, Three-arm, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Confirmed by Ultrasound
18 Years
47 Years
Female
Uterine Fibroids
Trial Information
A Phase 2, Three-arm, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Confirmed by Ultrasound
This study is a phase II, 3 arm study with a 12 week active dosing period. The study will
be conducted in 2 stages. In the first stage, the first 6 women to be enrolled will be
treated at the 12mg dose level, and in addition to the other required study assessments will
be monitored with a 24-hour PK assessment on Day 14, and daily trough assessments for the
first 14 days. If, at Visit 3, the Cmax or AUC of any subject treated at 12mg exceeds the
mean observed for the highest safe oral dose administered in the ZP-204 study, all subjects
enrolled at the 12mg level will be discontinued, no further patients will be treated at this
dose level, and the 6mg vaginal dose will be assessed in a similar fashion. In the second
stage, the remaining subjects will be randomized to a dose of 3, 6 or 12 mg.
For all subjects there will be a 4-6 week placebo run-in period, to establish baseline
parameters (bleeding and quality of life) followed by treatment at one of three single-blind
Proellex doses (3, 6 or 12 mg daily, administered vaginally in capsule form.) The primary
efficacy endpoint will be bleeding assessed using the PBAC after 12 weeks of treatment. The
secondary endpoints will be changes in size of uterine fibroids assessed by MRI and
improvement in quality of life assessed using the UFSQOL. Safety endpoints include
significant adverse events, changes in physical examination results, and/or clinical
laboratory results significantly outside of normal range. For subjects enrolled in Stage 2,
PK will be assessed after the first and last doses and trough levels every 2 weeks.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Vaginal Bleeding
Outcome Description:
Change in vaginal bleeding from baseline to 12 weeks of treatment
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Ronald D Wiehle, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Repros Therapeutics Inc.
Authority:
United States: Food and Drug Administration
Study ID:
ZPV-200
NCT ID:
NCT01451424
Start Date:
February 2012
Completion Date:
January 2013
Related Keywords:
- Uterine Fibroids
- Leiomyoma
- Myofibroma
Name | Location |
|---|---|
| Miami, Florida 33176 | |
| Austin, Texas 78705 |
