CompletedNCT01187043Updated Jul 28, 2014Results posted

Determination of the Lowest, Safe and Effective Dose of Proellex

A Phase 1/2 interventional study of Proellex in Amenorrhea, sponsored by Repros Therapeutics Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-28.

Sponsored by Repros Therapeutics Inc. · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 52
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: Female

Study summary

The purpose of this study is to determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.

Read the detailed description

A phase I/II, 5 arm, single blind study, comparing five doses of Proellex to matching placebo in healthy adult female subjects of reproductive age. Exposure to study drug will be for up to 10 weeks. In-clinic pharmacokinetic (PK) assessments will be made on the first day of dosing and on the last day (week 10). Office visits will occur every week to assess liver function and trough blood concentrations for Proellex and primary metabolite. Daily vaginal bleeding diaries will be maintained during the course of the study. A single blind run-in period of up to 56 days will begin the study to assess baseline menstrual patterns will be utilized. Twelve subjects per treatment group (total 60 subjects) will be assigned to each dose. New groups will not begin dosing until the previous dose group has completed. Daily treatments will be either 1 mg, 3 mg, 6 mg, 9 mg, 12 mg Proellex. A single blind run-in period using placebo will be incorporated to establish baseline parameters.

Conditions studied

Amenorrhea

Browse trials for

Amenorrhea 80

Keywords

Liver Function
Steady State Exposure

In context

Amenorrhea

80 studies on the registry are indexed under Amenorrhea; 13 are open to participants now.

This study's enrollment of 52 is below the median of 60 across 43 interventional studies indexed under Amenorrhea.

Browse Amenorrhea studies →

Lead sponsor

Repros Therapeutics Inc. is the lead sponsor of 57 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Ability to understand and provide a written informed consent.
Healthy adult females between 18 and 50 years of age. Included in this group are women with the following conditions, not currently receiving drug treatment:
- Excessive menstrual bleeding;
- Menstrual pain;
- Confirmed uterine fibroids; and
- Confirmed endometriosis
Normal menstrual cycle of 26-32 days
Agree not to attempt to become pregnant
Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours of each visit
Ability to swallow gelatin capsules 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

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 7 month study period
Women with abnormal liver enzymes or liver disease.
Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003, ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307.
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 or hormone releasing IUDs in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months.
Women currently using narcotics
Women currently taking cimetidine or spironolactone
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

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 52 participants (actual)

Study arms

Experimental
ARM 1
1 mg Proellex
Drug: Proellex
Experimental
ARM 2
3 mg Proellex
Drug: Proellex
Experimental
ARM 3
6 mg Proellex
Drug: Proellex
Experimental
ARM 4
9 mg Proellex
Drug: Proellex
Experimental
ARM 5
12 mg proellex
Drug: Proellex

Interventions

DrugProellex
1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Also known as: CDB-4124, Telapristone acetate

What researchers measure

Primary outcomes

Induction Amenorrhea
Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.
Time frame: 10 weeks

Results

Posted Jul 28, 2014

Participant flow

Participant flow — Overall Study
Milestone	ARM 1	ARM 2	ARM 3	ARM 4	ARM 5
Started	12	10	12	12	12
Completed	11	10	8	12	10
Not completed	1	0	4	0	2
Withdrew: Adverse event	0	0	0	0	1
Withdrew: Unable to make scheduled visits	1	0	4	0	1

Outcome measures

PrimaryInduction Amenorrhea

Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.

Time frame:: 10 weeks
Reported as:: Number · participants

Induction Amenorrhea
participants	ARM 1	ARM 2	ARM 3	ARM 4	ARM 5
Induction Amenorrhea	2	9	6	8	6

Adverse events

Collected over From first dose to one week post dosing (about 11 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ARM 1	—	0/12 (0%)	8/12 (66.7%)
ARM 2	—	0/10 (0%)	6/10 (60%)
ARM 3	—	1/12 (8.3%)	7/12 (58.3%)
ARM 4	—	0/12 (0%)	11/12 (91.7%)
ARM 5	—	0/12 (0%)	11/12 (91.7%)

Most frequent serious events

Most frequent serious events
Event	ARM 1	ARM 2	ARM 3	ARM 4	ARM 5
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/12	0/10	1/12	0/12	0/12

Most frequent other events

Showing 10 of 53

Most frequent other events
Event	ARM 1	ARM 2	ARM 3	ARM 4	ARM 5
HeadacheNervous system disorders	1/12	1/10	1/12	1/12	4/12
Hot flashesVascular disorders	1/12	0/10	0/12	2/12	3/12
EmesisGastrointestinal disorders	0/12	0/10	2/12	1/12	0/12
NauseaGastrointestinal disorders	2/12	0/10	2/12	1/12	1/12
GastroenteritisInfections and infestations	0/12	0/10	0/12	2/12	0/12
URIInfections and infestations	1/12	1/10	0/12	2/12	1/12
LacerationInjury, poisoning and procedural complications	0/12	0/10	0/12	2/12	0/12
DizzinessNervous system disorders	2/12	0/10	0/12	2/12	0/12
MenorrhagiaReproductive system and breast disorders	0/12	1/10	0/12	2/12	0/12
Right ear acheEar and labyrinth disorders	0/12	1/10	0/12	0/12	0/12

Baseline characteristics

ITT

Age, Continuous
Age, Continuous(years)	ARM 1	ARM 2	ARM 3	ARM 4	ARM 5	Total
Mean	37.4 ± 7.8	38.5 ± 7.6	37.1 ± 8.6	34.4 ± 8.3	36.3 ± 7.0	36.7 ± 7.8

Sex: Female, Male
Sex: Female, Male(Participants)	ARM 1	ARM 2	ARM 3	ARM 4	ARM 5	Total
Female	12	10	12	12	12	58
Male	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	ARM 1	ARM 2	ARM 3	ARM 4	ARM 5	Total
United States	12	10	12	12	12	58

Study locations

1 site

ICON Devlopment Solutions
San Antonio, Texas 78209, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01187043
Lead sponsor: Repros Therapeutics Inc.
Responsible party: Sponsor
First posted: Aug 23, 2010
Start date: Aug 2010
Primary completion: Mar 2012
Completion: Mar 2012
Results posted: Jul 28, 2014
Last update: Jul 28, 2014

Study contacts

Laura M Sterling, MD

principal investigator · ICON Development Solutions

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Amenorrhea→

Other studies from this sponsor

Repros Therapeutics Inc.

Start the discussion