Uterine FibroidsPhase 2NCT01451424
Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
A Phase 2 study testing Proellex in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 2 sites in United States.
Trial summary
To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally. 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?
- Proellex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Jan 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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
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- 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.
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 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Advances in Health
Houston, Texas, 77030
Cetero Research
Miami Gardens, Florida, 33169
About this study
Official title: A Phase 2, 3 Arm, Randomized, Double-Blind Study to Evaluate the Safety, PK and Efficacy of Proellex® Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids
To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally.
Read the detailed description
This study is a phase II, 5 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, 12 or 24 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 Pictorial Blood Loss Assessment Chart (PBAC) after 12 or 16 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 Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFSQOL0. 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.
- Conditions
- Uterine Fibroids
- Being tested
- Proellex
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProellexDrug
Also called Telapristone acetate
vaginal suppository, daily, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Proellex 12 mg PK group | Experimental | Subjects receiving 12 mg Proellex administered vaginally, and completing a PK arm consisting of 1 x 24 hr PK of Proellex, 14 days of daily Proellex trough measurements, and 1 x 24 hr PK of Proellex after 14 days of daily dosing. 12 mg PK subjects will continue with the protocol as written after the first 2 week period and will be treated for a total of 16 weeks. Receives: Drug: Proellex |
| Proellex 12 mg per protocol | Experimental | Subjects receiving 12 mg Proellex daily, vaginally for 12 weeks Receives: Drug: Proellex |
| Proellex 6 mg per protocol | Experimental | Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks Receives: Drug: Proellex |
| Proellex 3 mg per protocol | Experimental | Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks. Receives: Drug: Proellex |
| 24 mg Proellex | Experimental | 24 mg vaginal Proellex daily for 16 weeks Receives: Drug: Proellex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Vaginal Bleeding
Change from baseline in vaginal bleeding assessed at the end of treatment (12 or 16 weeks) using a Pictorial Blood Loss Assessment Chart (PBAC), which measures volume (mL) of blood loss over a 28-day period
Less blood loss represents an improvement.
Measured: 12 or 16 weeks
Secondary outcomes (5)
Blood Levels of Proellex
Determination of Cmax of Proellex at end of treatment
Measured: 12 or 16 weeks
Uterine Fibroid Size
Percent change in volume of confirmed uterine fibroids at end of treatment, assessed by MRI
Measured: 12 or 16 weeks
Induction of Amenorrhea at End of Treatment
Percentage of subjects with induced amenorrhea during last 28 days on drug
Amenorrhea was deemed to be achieved if no daily bleeding score was greater than 1 during the last 28 calendar days of the dosing period. A score of 1 was to be indicated if spotting was observed which did not require a sanitary product. Subjects that terminated early were deemed not to have achieved amenorrhea.
Measured: End of treatment
Endometrial Thickness
Percent change in median endometrial thickness from baseline to end of treatment assessed by ultrasound determination of uterine stripe.
Measured: 12 or 16 weeks
Change in Quality of Life
Percentage change from baseline in median quality of life using uterine fibroid symptom and quality of life questionnaire (UFSQOL)
Measured: 12 or 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald D Wiehle, PhD, Study director, Repros Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451424
- Sponsor's protocol ID
- ZPV-200
- Status last verified
- Aug 2014
- First submitted
- 11 Oct 2011
- Last updated
- 29 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, 3 Arm, Randomized, Double-Blind Study to Evaluate the Safety, PK and Efficacy of Proellex® Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids
- ClinicalTrials.gov ID
- NCT01451424
- Acronym / sponsor ID
- ZPV-200
- Conditions
- Uterine Fibroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Oct 2011 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally.
Detailed description
This study is a phase II, 5 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, 12 or 24 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 Pictorial Blood Loss Assessment Chart (PBAC) after 12 or 16 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 Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFSQOL0. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Proellex 12 mg PK group | Experimental | Drug: ProellexSubjects receiving 12 mg Proellex administered vaginally, and completing a PK arm consisting of 1 x 24 hr PK of Proellex, 14 days of daily Proellex trough measurements, and 1 x 24 hr PK of Proellex after 14 days of daily dosing. 12 mg PK subjects will continue with the protocol as written after the first 2 week period and will be treated for a total of 16 weeks. |
| Proellex 12 mg per protocol | Experimental | Drug: ProellexSubjects receiving 12 mg Proellex daily, vaginally for 12 weeks |
| Proellex 6 mg per protocol | Experimental | Drug: ProellexSubjects receiving 6 mg Proellex daily, vaginally for 12 weeks |
| Proellex 3 mg per protocol | Experimental | Drug: ProellexSubjects will receive 3 mg Proellex daily, vaginally for 12 weeks. |
| 24 mg Proellex | Experimental | Drug: Proellex24 mg vaginal Proellex daily for 16 weeks |
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 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
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 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
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 |
|---|---|---|
| ProellexAlso: Telapristone acetatevaginal suppository, daily, for 12 weeks | Drug | 24 mg Proellex, Proellex 12 mg PK group, Proellex 12 mg per protocol, Proellex 3 mg per protocol, Proellex 6 mg per protocol |
Primary outcome
Change From Baseline in Vaginal Bleeding
Time frame: 12 or 16 weeks
Change from baseline in vaginal bleeding assessed at the end of treatment (12 or 16 weeks) using a Pictorial Blood Loss Assessment Chart (PBAC), which measures volume (mL) of blood loss over a 28-day period Less blood loss represents an improvement.
5 secondary outcomes
Blood Levels of Proellex
Time frame: 12 or 16 weeks
Uterine Fibroid Size
Time frame: 12 or 16 weeks
Induction of Amenorrhea at End of Treatment
Time frame: End of treatment
Endometrial Thickness
Time frame: 12 or 16 weeks
Change in Quality of Life
Time frame: 12 or 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Repros Therapeutics Inc corporate websiteLink 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.
Ronald D Wiehle, PhD study director
Repros Therapeutics Inc.
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 Proellex 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 29 Aug 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?
Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Vaginal Bleeding (time frame: 12 or 16 weeks). 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 29 Aug 2014.