AmenorrheaPhase 1NCT00881608
Study to Evaluate Menses Induction in Women Administered Proellex
A Phase 1 study testing Proellex in people with Amenorrhea, run by Repros Therapeutics Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amenorrhea
- What is being tested?
- Proellex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Aug 2009
- Phase
- Phase 1
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical laboratory tests within normal ranges
- A normal menstrual period of 26-30 days
- Desiring not to become pregnant
- Agreeing to use a double barrier method of birth control for the duration of the trial
Who cannot join
- Post-menopausal status
- Aamenorrhea or dysfunctional uterine bleeding
- Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile
- Subjects with a Body Mass Index (BMI) below 18 or over 39
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Escalating Dose, Single Center, Cross-over Design, Phase I Study to Evaluate Menses Induction in Women Administered Proellex
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.
Read the detailed description
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able to suppress endogenous progesterone in women. It is believed that giving Proellex in the early/mid-luteal phase of the cycle will suppress the effects of endogenous progesterone triggering the end of the cycle and inducing menstruation as happens naturally
- Conditions
- Amenorrhea
- Being tested
- Placebo, Proellex
- Keywords
- Menstruation
- Medical subject headings
- Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Dummy
Placebo, 1 capsule daily for five days
ProellexDrug
Also called Telapristone acetate
Proellex, one 3, 6, 12 or 25 mg capsule daily for five days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18. Receives: Drug: Placebo |
| 3 mg Proellex | Experimental | First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18. Receives: Drug: Proellex |
| 6 mg Proellex | Experimental | Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18. Receives: Drug: Proellex |
| 12 mg Proellex | Experimental | Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18. Receives: Drug: Proellex |
| 25 mg Proellex | Experimental | Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18. Receives: Drug: Proellex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day of Initial Vaginal Bleeding Event Following Treatment With Proellex.
Measured: An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses
Secondary outcomes (1)
Duration of Vaginal Bleeding Following Treatment With Proellex.
Measured: At least 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Repros stopped study for safety and the FDA put the study on hold for safety.
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 AmenorrheaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andre van As, M.D., Ph.D, Study director, Repros Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881608
- Sponsor's protocol ID
- ZP-010
- Status last verified
- Aug 2014
- First submitted
- 14 Apr 2009
- Last updated
- 25 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 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Escalating Dose, Single Center, Cross-over Design, Phase I Study to Evaluate Menses Induction in Women Administered Proellex
- ClinicalTrials.gov ID
- NCT00881608
- Acronym / sponsor ID
- ZP-010
- Conditions
- Amenorrhea
- Keywords
- Menstruation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Repros stopped study for safety and the FDA put the study on hold for safety.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Posted 25 Aug 2014
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 oral dose level at which the investigative drug, Proellex, is able induce menstruation.
Detailed description
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able to suppress endogenous progesterone in women. It is believed that giving Proellex in the early/mid-luteal phase of the cycle will suppress the effects of endogenous progesterone triggering the end of the cycle and inducing menstruation as happens naturally
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboInitiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18. |
| 3 mg Proellex | Experimental | Drug: ProellexFirst Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18. |
| 6 mg Proellex | Experimental | Drug: ProellexSecond Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18. |
| 12 mg Proellex | Experimental | Drug: ProellexThird Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18. |
| 25 mg Proellex | Experimental | Drug: ProellexFourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical laboratory tests within normal ranges
- A normal menstrual period of 26-30 days
- Desiring not to become pregnant
- Agreeing to use a double barrier method of birth control for the duration of the trial
Key exclusion criteria (4 listed)
- Post-menopausal status
- Aamenorrhea or dysfunctional uterine bleeding
- Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile
- Subjects with a Body Mass Index (BMI) below 18 or over 39
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 |
|---|---|---|
| PlaceboAlso: DummyPlacebo, 1 capsule daily for five days | Drug | Placebo |
| ProellexAlso: Telapristone acetateProellex, one 3, 6, 12 or 25 mg capsule daily for five days | Drug | 12 mg Proellex, 25 mg Proellex, 3 mg Proellex, 6 mg Proellex |
Primary outcome
Day of Initial Vaginal Bleeding Event Following Treatment With Proellex.
Time frame: An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses
1 secondary outcome
Duration of Vaginal Bleeding Following Treatment With Proellex.
Time frame: At least 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andre van As, M.D., Ph.D study director
Repros Therapeutics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Proellex in people with Amenorrhea, run by Repros Therapeutics Inc. at 1 site 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 25 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 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 25 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?
Day of Initial Vaginal Bleeding Event Following Treatment With Proellex. (time frame: An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses). 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 25 Aug 2014.