Uterine Fibroids, Anemia
Conditions
Keywords
Uterine fibroids, Anemia
Brief summary
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.
Detailed description
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.
Interventions
DRUGProellex 25 mg
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
DRUGProellex 50 mg
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
DRUGPlacebo
Placebo, 2 capsules daily for 3 months
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
Inclusion criteria
* Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive; * Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding; * Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study; * Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits
Exclusion criteria
* Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following: * Six months or more (immediately prior to Screening Visit) without a menstrual period, or * Prior hysterectomy, or * Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring); * Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause; * Documented endometriosis or active pelvic inflammatory disease (PID); * Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs; * Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia; * Use of prohibited concomitant medications: 1. Depo-Provera use must cease ten months prior to first dose of study drug, or 2. GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or 3. Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months. | 3 months |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 25 mg Proellex Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months | 0 |
| Proellex 50 mg Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months | 0 |
| Placebo Placebo: Placebo, 2 capsules daily for 3 months | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study prematurely terminated | 8 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | — Participants |
| Age, Categorical >=65 years | — Participants |
| Age, Categorical Between 18 and 65 years | — Participants |
| Region of Enrollment Mexico | — participants |
| Sex: Female, Male Female | — Participants |
| Sex: Female, Male Male | — Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.
Time frame: 3 months