A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Repros Therapeutics Inc.
Age
18–47
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Is a pre-menopausal female, between 18 and 47 years
Participant has a history of at least 3 regular menstrual cycles in which menorrhagia (heavy bleeding) is due to uterine fibroids
Confirmed uterine fibroid(s) at screening
Visit 1 historical pictorial blood loss assessment chart of \>120 milliliters (mL) of blood loss, to ensure participants have a menstrual blood loss of at least 80 mL by Alkaline Hematin Assay (during the baseline assessment period).
A Body Mass Index (BMI) between 18 and 45 inclusive
You may not be if
Participant is 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
Has an intrauterine device in place
Observation or history of abnormal endometrial biopsy including the presence of endometrial intraepithelial neoplasia
Participants with abnormally high liver enzymes or liver disease
Clareo Health | A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
