Uterine FibroidsPhase 2NCT01631903
Extension of Study ZPV-200
A Phase 2 study testing telepristone acetate 12 mg, telepristone acetate 3 mg and telepristone acetate 6 mg in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- telepristone acetate 12 mg, telepristone acetate 3 mg and telepristone acetate 6 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 47 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy adult females between 18 and 47 years of age with uterine fibroids confirmed by ultrasound. Normal, or abnormal but non-clinically significant, transvaginal ultrasound. 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 and study procedures in compliance with the protocol.
- Agrees to use the condoms provided and no other method of birth control (hormonal methods, contraceptive sponge, spermicide or cervical cap) 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 providing verification of surgical sterilization.
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- A Body Mass Index (BMI) between 18 and 39 inclusive.
- Is available for all treatment and follow-up visits.
- Subject is able to insert vaginal suppositories.
- Subject is willing to exclusively use sanitary napkins (no tampons) during study duration.
Who cannot join
- 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 abnormally high liver enzymes or liver disease. (ALT or AST exceeding 1.5x ULN 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.
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- Use of oral contraceptives in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months.
- Has an IUD in place.
- 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.
- Participation in study ZP-204.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Houston, Texas, 77030
Study site
Miami Gardens, Florida, 33169
About this study
Official title: A Phase 2, Multi-Center, Five-Arm, Parallel Design, Randomized, Single-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
The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.
- Conditions
- Uterine Fibroids
- Being tested
- telepristone acetate 12 mg, telepristone acetate 3 mg, telepristone acetate 6 mg, telepristone acetate 24 mg
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telepristone acetate 12 mgDrug
Also called Proellex
12 mg, vaginal capsule, once daily for 4 months
telepristone acetate 3 mgDrug
Also called Proellex
3 mg, vaginal capsule, once daily for 3 months
telepristone acetate 6 mgDrug
Also called Proellex
6 mg, vaginal capsule, once daily for 3 months
telepristone acetate 12 mgDrug
Also called Proellex
12 mg, vaginal capsule, once daily, for 3 months
telepristone acetate 24 mgDrug
Also called Proellex
24 mg, vaginal capsule, once daily for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 (3mg) | Experimental | Not described Receives: Drug: telepristone acetate 3 mg |
| Arm 3 (6 mg) | Experimental | Not described Receives: Drug: telepristone acetate 6 mg |
| Arm 4 (12 mg) | Experimental | Not described Receives: Drug: telepristone acetate 12 mg |
| Arm 5 (24 mg) | Experimental | Not described Receives: Drug: telepristone acetate 24 mg |
| PK arm (12 mg) | Experimental | PK arm requires one additional 24 hour PK assessment at V3 and daily visits between visits 2 and 3 for drug trough sample collection Receives: Drug: telepristone acetate 12 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Scores
The primary efficacy endpoint will be bleeding assessed using the change in PBAC scores from the 4 weeks prior to Visit 2 to the 4 weeks prior to Visit 10
Measured: 3 or 4 months depending on treatment arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631903
- Sponsor's protocol ID
- ZPV-200 EXT
- Status last verified
- Nov 2012
- First submitted
- 27 Jun 2012
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Five-Arm, Parallel Design, Randomized, Single-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
- ClinicalTrials.gov ID
- NCT01631903
- Acronym / sponsor ID
- ZPV-200 EXT
- Conditions
- Uterine Fibroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 2 (3mg) | Experimental | Drug: telepristone acetate 3 mg |
| Arm 3 (6 mg) | Experimental | Drug: telepristone acetate 6 mg |
| Arm 4 (12 mg) | Experimental | Drug: telepristone acetate 12 mg |
| Arm 5 (24 mg) | Experimental | Drug: telepristone acetate 24 mg |
| PK arm (12 mg) | Experimental | Drug: telepristone acetate 12 mgPK arm requires one additional 24 hour PK assessment at V3 and daily visits between visits 2 and 3 for drug trough sample collection |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy adult females between 18 and 47 years of age with uterine fibroids confirmed by ultrasound. Normal, or abnormal but non-clinically significant, transvaginal ultrasound. 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 and study procedures in compliance with the protocol.
- Agrees to use the condoms provided and no other method of birth control (hormonal methods, contraceptive sponge, spermicide or cervical cap) over the course of the study.
Key exclusion criteria (12 listed)
- 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 abnormally high liver enzymes or liver disease. (ALT or AST exceeding 1.5x ULN 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telepristone acetate 12 mgAlso: Proellex12 mg, vaginal capsule, once daily for 4 months | Drug | PK arm (12 mg) |
| telepristone acetate 3 mgAlso: Proellex3 mg, vaginal capsule, once daily for 3 months | Drug | Arm 2 (3mg) |
| telepristone acetate 6 mgAlso: Proellex6 mg, vaginal capsule, once daily for 3 months | Drug | Arm 3 (6 mg) |
| telepristone acetate 12 mgAlso: Proellex12 mg, vaginal capsule, once daily, for 3 months | Drug | Arm 4 (12 mg) |
| telepristone acetate 24 mgAlso: Proellex24 mg, vaginal capsule, once daily for 4 months | Drug | Arm 5 (24 mg) |
Primary outcome
Bleeding Scores
Time frame: 3 or 4 months depending on treatment arm
The primary efficacy endpoint will be bleeding assessed using the change in PBAC scores from the 4 weeks prior to Visit 2 to the 4 weeks prior to Visit 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Sponsor's corporate web pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing telepristone acetate 12 mg, telepristone acetate 3 mg and telepristone acetate 6 mg in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding Scores (time frame: 3 or 4 months depending on treatment arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2014.