ContraceptionPhase 2NCT01107093
Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge
A Phase 2 study testing CDB-2914 (ulipristal acetate) in people with Contraception, run by HRA Pharma at 2 sites in 2 countries.
Trial summary
Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered after the onset of the LH surge on the outcome of the leading ovary follicle: echographic follicle rupture inhibition of follicle rupture luteal phase progesterone levels anovulatory progesterone levels 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
- What is being tested?
- CDB-2914 (ulipristal acetate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2008to Dec 2008
- 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 of good general health aged 18 - 35 years
- Not at risk of pregnancy
- Regular menstrual cycles of 24-35 days duration
- Not pregnant
- Intact uterus and ovaries
- Haemoglobin ≥ 11 g/dl
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- Normal laboratory tests and normal TSH
- Willing to abstain from any use of hormonal contraception until study completion
- No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since termination of previous hormonal contraception
- Had at least one complete menstrual cycle (2 menses) following delivery, miscarriage or induced abortion
- Able to give voluntary, written informed consent, and agreeing to observe all study requirements for 5 complete menstrual cycles
Who cannot join
- Current participation in any other trial of an investigational medicine
- Known hypersensitivity to the ingredients of the test active substances or excipients
- Suspected hyperplasia or carcinoma of the endometrium
- Current pregnancy as confirmed by positive serum beta-hCG at screening
- Desire to get pregnant before the planned end of the study participation
- Currently breastfeeding
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- Abnormal Pap smear
- Cancer (past history of any carcinoma or sarcoma)
- Known or suspected alcoholism or drug abuse
- Abnormal thyroid status
- Body mass index > 32
- Current use of hormonal contraception
- Use of hormonal emergency contraception since last menstrual period
- Severe asthma insufficiently controlled by oral glucocorticoids
- Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective, Randomized, Double-blind, Cross-Over Study to Compare the Capacity to Prevent Follicular Rupture of CDB-2914 With Placebo, When Administered After the Ovulatory Process Has Been Triggered by the LH Surge
Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered after the onset of the LH surge on the outcome of the leading ovary follicle:
- echographic follicle rupture
- inhibition of follicle rupture
- luteal phase progesterone levels
- anovulatory progesterone levels
- Conditions
- Contraception
- Being tested
- CDB-2914 (ulipristal acetate), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDB-2914 (ulipristal acetate)Drug
single oral dose of 30 mg
PlaceboDrug
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| CDB-2914 | Active comparator | Not described Receives: Drug: CDB-2914 (ulipristal acetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition of follicular rupture
Inhibition is calculated as the number of subjects exhibiting no dominant follicle rupture, divided by the total number of subjects having received treatment
Measured: within 6 days after treatment intake
Secondary outcomes (7)
Appearance or absence of a corpus luteum
Measured: during the 6 days following treatment intake
Growth pattern of leading follicle
number of cycles exhibiting atresia (diameter decrease ≥25%), or continued growth (diameter increase ≥25%), or interrupted growth (size remains within ±25% of the follicle size at the time of treatment)
Presence or absence of a surge of serum luteinizing hormone (LH) levels
The onset of an LH surge is defined as the occurrence of the first single serum LH value whose level is at least 50% higher than the mean of the last two previous measurements, or higher than the last previous measurement if only one previous LH level is available.
Menstrual cycle length in comparison to the subject's reported baseline average cycle length and to her placebo-treated cycle length
Incidence of intermenstrual bleeding and treatment-emergent adverse events
Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline
Incidence of ovarian cysts after CDB-2914 treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startMay 2008
- Primary completionDec 2008
- Study completionDec 2008
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- HRA Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107093
- Sponsor's protocol ID
- 2914-007
- Status last verified
- Aug 2010
- First submitted
- 12 Apr 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Brache V, Cochon L, Jesam C, Maldonado R, Salvatierra AM, Levy DP, Gainer E, Croxatto HB. Immediate pre-ovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod. 2010 Sep;25(9):2256-63. doi: 10.1093/humrep/deq157. Epub 2010 Jul 15.
PubMed 20634186
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Cross-Over Study to Compare the Capacity to Prevent Follicular Rupture of CDB-2914 With Placebo, When Administered After the Ovulatory Process Has Been Triggered by the LH Surge
- ClinicalTrials.gov ID
- NCT01107093
- Acronym / sponsor ID
- 2914-007
- Conditions
- Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- HRA PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Apr 2010 (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.
Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered after the onset of the LH surge on the outcome of the leading ovary follicle:
- echographic follicle rupture
- inhibition of follicle rupture
- luteal phase progesterone levels
- anovulatory progesterone levels
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| CDB-2914 | Active comparator | Drug: CDB-2914 (ulipristal acetate) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Women of good general health aged 18 - 35 years
- Not at risk of pregnancy
- Regular menstrual cycles of 24-35 days duration
- Not pregnant
- Intact uterus and ovaries
Key exclusion criteria (15 listed)
- Current participation in any other trial of an investigational medicine
- Known hypersensitivity to the ingredients of the test active substances or excipients
- Suspected hyperplasia or carcinoma of the endometrium
- Current pregnancy as confirmed by positive serum beta-hCG at screening
- Desire to get pregnant before the planned end of the study participation
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 |
|---|---|---|
| CDB-2914 (ulipristal acetate)single oral dose of 30 mg | Drug | CDB-2914 |
| Placebosingle oral dose | Drug | Placebo |
Primary outcome
Inhibition of follicular rupture
Time frame: within 6 days after treatment intake
Inhibition is calculated as the number of subjects exhibiting no dominant follicle rupture, divided by the total number of subjects having received treatment
7 secondary outcomes
Appearance or absence of a corpus luteum
Time frame: during the 6 days following treatment intake
Growth pattern of leading follicle
Presence or absence of a surge of serum luteinizing hormone (LH) levels
Menstrual cycle length in comparison to the subject's reported baseline average cycle length and to her placebo-treated cycle length
Incidence of intermenstrual bleeding and treatment-emergent adverse events
Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline
Incidence of ovarian cysts after CDB-2914 treatment
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 25 Aug 2010.
- Results publication: PubMed 20634186Brache V, Cochon L, Jesam C, Maldonado R, Salvatierra AM, Levy DP, Gainer E, Croxatto HB. Immediate pre-ovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod. 2010 Sep;25(9):2256-63. doi: 10.1093/humrep/deq157. Epub 2010 Jul 15.
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDB-2914 (ulipristal acetate) in people with Contraception, run by HRA Pharma at 2 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 11 inclusion and 15 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 25 Aug 2010. 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 Chile, Dominican Republic. 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 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?
Inhibition of follicular rupture (time frame: within 6 days after treatment intake). 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 NCT01107093, 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 25 Aug 2010.