Comparison of 2 Different Formulations of 12 mg Proellex Vaginal CapsulesPhase 1NCT01962805
Comparison of Two Formulations of Proellex for Vaginal Administration
A Phase 1 study testing Proellex Formulation A and Proellex Formulation B in people with Comparison of 2 Different Formulations of 12 mg Proellex Vaginal Capsules, run by Repros Therapeutics Inc. at 1 site in United States.
Trial summary
This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of either 1 or 6 days of dosing with two different formulations of Proellex for vaginal administration. Each formulation will be designated as either Treatment A or Treatment B. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Comparison of 2 Different Formulations of 12 mg Proellex Vaginal Capsules
- What is being tested?
- Proellex Formulation A and Proellex Formulation B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2013
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an institutional review board (IRB)-approved form prior to the initiation of any study procedures;
- Healthy, premenopausal female age 18-47;
- History of menstrual events that occur in regular cycles
- Agreement not to attempt to become pregnant
- Agrees to use a condom 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 visit. An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
- Normal laboratory values or clinically insignificant findings at screening as determined by the Investigator;
- Subject is willing to remain in the clinic overnight for PK assessment on Days 0, 6 or 8 and Day 14.
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 study
- Women with abnormally high liver enzymes or liver disease. Alanine transaminase (ALT) or aspartate aminotransferase (AST) exceeding 1.5 x upper limit of normal (ULN) AND total bilirubin exceeding 1.5 x ULN 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 polycystic ovary syndrome (PCOS)
- Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, dehydroepiandrosterone (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 intrauterine device (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
1 site in 1 country.
About this study
Official title: A Double-Blind, Crossover Study in Healthy Volunteers to Compare Two Formulations of Proellex for Vaginal Administration
This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of either 1 or 6 days of dosing with two different formulations of Proellex for vaginal administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 8 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. Subjects will receive a single dose of Treatment A or daily dosing with Treatment B for 6 days. After a 7-day washout period subjects will receive the alternative treatment. On the day of treatment with Treatment A and on the first and last days of treatment with Treatment B subjects will remain in the clinic overnight and undergo 32-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 4, 8, 12, 16, 20, 24, 28 and 32 hours after administration of study drug. For Treatment B study drug will be administered in the clinic each day after a trough blood sample has been drawn.
- Being tested
- Proellex Formulation A, Proellex Formulation B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proellex Formulation ADrug
Also called telepristone acetate
Proellex Formulation BDrug
Also called telepristone acetate
| Study group | Role | What they receive |
|---|---|---|
| Proellex Schedule A | Experimental | Proellex vaginal capsule, 12 mg, once a day for up to 7 days Receives: Drug: Proellex Formulation A; Drug: Proellex Formulation B |
| Proellex Schedule B | Experimental | Proellex vaginal capsule, 12 mg, once a day for up to 7 days Receives: Drug: Proellex Formulation A; Drug: Proellex Formulation B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
To determine and compare the maximum measured plasma concentration over the final dosing interval(Cmax) of two formulations of 12 mg Proellex administered vaginally in female healthy volunteers once daily for up to 7 days.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of 2 Different Formulations of 12 mg Proellex Vaginal CapsulesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962805
- Sponsor's protocol ID
- ZPV-101
- Status last verified
- Jan 2014
- First submitted
- 9 Oct 2013
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Crossover Study in Healthy Volunteers to Compare Two Formulations of Proellex for Vaginal Administration
- ClinicalTrials.gov ID
- NCT01962805
- Acronym / sponsor ID
- ZPV-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Oct 2013 (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.
This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of either 1 or 6 days of dosing with two different formulations of Proellex for vaginal administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 8 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. Subjects will receive a single dose of Treatment A or daily dosing with Treatment B for 6 days. After a 7-day washout period subjects will receive the alternative treatment. On the day of treatment with Treatment A and on the first and last days of treatment with Treatment B subjects will remain in the clinic overnight and undergo 32-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 4, 8, 12, 16, 20, 24, 28 and 32 hours after administration of study drug. For Treatment B study drug will be administered in the clinic each day after a trough blood sample has been drawn.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proellex Schedule A | Experimental | Drug: Proellex Formulation A, Drug: Proellex Formulation BProellex vaginal capsule, 12 mg, once a day for up to 7 days |
| Proellex Schedule B | Experimental | Drug: Proellex Formulation A, Drug: Proellex Formulation BProellex vaginal capsule, 12 mg, once a day for up to 7 days |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an institutional review board (IRB)-approved form prior to the initiation of any study procedures;
- Healthy, premenopausal female age 18-47;
- History of menstrual events that occur in regular cycles
- Agreement not to attempt to become pregnant
- Agrees to use a condom 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 study
- Women with abnormally high liver enzymes or liver disease. Alanine transaminase (ALT) or aspartate aminotransferase (AST) exceeding 1.5 x upper limit of normal (ULN) AND total bilirubin exceeding 1.5 x ULN 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 polycystic ovary syndrome (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 |
|---|---|---|
| Proellex Formulation AAlso: telepristone acetate | Drug | Proellex Schedule A, Proellex Schedule B |
| Proellex Formulation BAlso: telepristone acetate | Drug | Proellex Schedule A, Proellex Schedule B |
Primary outcome
Cmax
Time frame: 7 days
To determine and compare the maximum measured plasma concentration over the final dosing interval(Cmax) of two formulations of 12 mg Proellex administered vaginally in female healthy volunteers once daily for up to 7 days.
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 24 Jan 2014.
- Sponsor corporate websiteLink provided by the sponsor.
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.
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 Formulation A and Proellex Formulation B in people with Comparison of 2 Different Formulations of 12 mg Proellex Vaginal Capsules, 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 8 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 24 Jan 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. 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?
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?
Cmax (time frame: 7 days). 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 24 Jan 2014.