ContraceptionPhase 2NCT00456924
Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914
A Phase 2 study testing VA2914 in people with Contraception and Gynecologic Diseases, run by HRA Pharma at 4 sites in 2 countries.
Trial summary
The purpose of the present study is to evaluate continuous administration of low doses of VA2914 for potential contraceptive activity and effects on the menstrual cycle and steroid hormone parameters. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Gynecologic Diseases
- What is being tested?
- VA2914
- How many people
- 48 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2004to Dec 2004
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women in good general health with regular, ovulatory menstrual cycles
- age 18-35
- not pregnant
- not sexually active or reliably use barrier methods of contraception
- normal liver and renal functions and normal laboratory exams
Who cannot join
- pregnant or breastfeeding
- oral contraception, IUD or other hormonal treatment
- use of agents known to induce hepatic P450
- cardiovascular disorder
- hepatic, renal, or gastrointestinal disorder
- metrorrhagia
Show all 20Show fewer
- abnormal transvaginal ultrasound (at baseline)
- history of abnormal endometrial biopsy,
- cancer
- depression
- mental illness
- epilepsy
- migraines
- abnormal Pap Smear requiring further exploratory examination
- anovulatory cycle before treatment
- extreme overweight or underweight (body mass index < 16 ou >28)
- subjects unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- use of narcotics
- more than 10 cigarettes per day, more than 2 glasses of wine/beer per day
- surgical procedures planned in the 6 months following screening visit
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
About this study
Official title: Prospective Randomized Multicenter Phase II Study of the Dose-Response Effects of Continuous Administration of Low-Dose VA2914 on Parameters of the Hypothalamic-Pituitary-Gonadal Axis and the Endometrium
The purpose of the present study is to evaluate continuous administration of low doses of VA2914 for potential contraceptive activity and effects on the menstrual cycle and steroid hormone parameters.
- Conditions
- Contraception, Gynecologic Diseases
- Being tested
- VA2914
- Keywords
- progesterone receptor modulator
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA2914Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
ovarian hormones
follicular development
endometrial histology
Secondary outcomes (5)
menstural bleeding patterns
cervical mucus
VA2914 concentration
adverse events
laboratory parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startJan 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies 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
- Double blind
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- HRA Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philippe Bouchard, MD, Principal investigator, Saint Antoine Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456924
- Sponsor's protocol ID
- 2914-002
- Status last verified
- Jun 2010
- First submitted
- 4 Apr 2007
- Last updated
- 17 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Chabbert-Buffet N, Pintiaux-Kairis A, Bouchard P; VA2914 Study Group. Effects of the progesterone receptor modulator VA2914 in a continuous low dose on the hypothalamic-pituitary-ovarian axis and endometrium in normal women: a prospective, randomized, placebo-controlled trial. J Clin Endocrinol Metab. 2007 Sep;92(9):3582-9. doi: 10.1210/jc.2006-2816. Epub 2007 Jun 19.
PubMed 17579200
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Multicenter Phase II Study of the Dose-Response Effects of Continuous Administration of Low-Dose VA2914 on Parameters of the Hypothalamic-Pituitary-Gonadal Axis and the Endometrium
- ClinicalTrials.gov ID
- NCT00456924
- Acronym / sponsor ID
- 2914-002
- Conditions
- Contraception, Gynecologic Diseases
- Keywords
- progesterone receptor modulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- HRA PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Dec 2004 (actual)
- First posted
- 5 Apr 2007 (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 the present study is to evaluate continuous administration of low doses of VA2914 for potential contraceptive activity and effects on the menstrual cycle and steroid hormone parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women in good general health with regular, ovulatory menstrual cycles
- age 18-35
- not pregnant
- not sexually active or reliably use barrier methods of contraception
- normal liver and renal functions and normal laboratory exams
Key exclusion criteria (20 listed)
- pregnant or breastfeeding
- oral contraception, IUD or other hormonal treatment
- use of agents known to induce hepatic P450
- cardiovascular disorder
- hepatic, renal, or gastrointestinal disorder
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 |
|---|---|---|
| VA2914 | Drug | – |
Primary outcome
ovarian hormones
follicular development
endometrial histology
5 secondary outcomes
menstural bleeding patterns
cervical mucus
VA2914 concentration
adverse events
laboratory parameters
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 17 Jun 2010.
- Results publication: PubMed 17579200Chabbert-Buffet N, Pintiaux-Kairis A, Bouchard P; VA2914 Study Group. Effects of the progesterone receptor modulator VA2914 in a continuous low dose on the hypothalamic-pituitary-ovarian axis and endometrium in normal women: a prospective, randomized, placebo-controlled trial. J Clin Endocrinol Metab. 2007 Sep;92(9):3582-9. doi: 10.1210/jc.2006-2816. Epub 2007 Jun 19.
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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.
Philippe Bouchard, MD principal investigator
Saint Antoine Hospital, Paris, France
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VA2914 in people with Contraception and Gynecologic Diseases, run by HRA Pharma at 4 sites in 2 countries.
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 5 inclusion and 20 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 17 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France. 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?
ovarian hormones. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00456924, which also lists 1 linked publication.
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 17 Jun 2010.