ContraceptionPhase 2NCT00791297
Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914
A Phase 2 study testing CDB-2914 in people with Contraception, run by Population Council at 3 sites in 3 countries.
Trial summary
The purpose of this study is to to determine pharmacodynamic effects of a vaginal ring delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on: 1. follicular function and inhibition of ovulation 2. the endometrium 3. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- CDB-2914
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2008to Sep 2014
- 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women of reproductive age (21-40 years)
- Not at risk for pregnancy based on one of the following
- subject has undergone sterilization
- subject is monogamous and her male partner has undergone sterilization
- subject agrees to be abstinent for the entire duration of the study (Oregon site only)
- subject does not have sex with men (Oregon site only)
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- Have regular menstrual cycles of 25-35 days duration
- Have an intact uterus and both ovaries
- Will be able to comply with the protocol
- Capable of giving informed consent
Who cannot join
- Women participating in another clinical trial
- Women not living in the catchment area of the clinic
- Known hypersensitivity to progestins or antiprogestins
- Known hypersensitivity to silicone rubber
- Any chronic disease
- All contraindications to oral contraceptive use, including
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- Thrombophlebitis or thromboembolic disorders
- Past history of deep vein thrombophlebitis or thromboembolic disorders
- Past or current cerebrovascular or coronary artery disease
- Migraine with focal aura
- Known or suspected carcinoma of the breast
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior pill use
- Hepatic adenomas or carcinomas
- Known or suspected pregnancy
- Desire to get pregnant during the study (through the use of reproductive technology for sterilized women or vasectomy reversal for sterilized partners)
- Breastfeeding
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities
- Elevated Prolactin levels (above laboratory normal values)
- Women with a current abnormal Pap
- In accordance with the Bethesda system of classification smear suggestive of high-grade pre-cancerous lesion(s), including HGSIL, are excluded
- Women with LGSIL or ASCUS/high-risk HPV positive may participate if further evaluated with colposcopy and biopsy and no evidence of a lesion with a severity > CIN I is present and/or endocervical curettage is negative
- Women with a biopsy finding of CIN I should have follow up for this finding per standard of care; women are excluded it treatment is indicated
- In accordance with other Pap class systems
- Women with high grade dysplasia are excluded
- Women with low grade dysplasia or CIN I interpretation on Pap smear may participate based on Investigator discretion and provided there is appropriate follow up in accordance with local standards of care
- Known benign or malignant liver tumors; known active liver disease
- Cancer (past history of any carcinoma or sarcoma)
- Medically diagnosed severe depression currently or in the past
- Known or suspected alcoholism or drug abuse
- Abnormal serum fasting clinical chemistry values
- Women with known abnormal thyroid status
- Women with known impaired hypothalamic-pituitary-adrenal reserve
- Average diastolic BP > 85 mm or systolic BP >135 mm Hg after 5-10 minutes rest
- Body mass index(BMI) > 29.0
- Smoking in women who are 35 years and over or will be 35 years during the course of the trial; women < 35 years who smoke greater than 15 cigarettes per day must be evaluated by the PI for inclusion based on risk factors that would increase their risk for CVD and thromboembolism, e.g. lipid levels, glucose level, BP, BMI, family history of CVD at a young age
- Women with severe cystoceles or rectoceles
- Use within the past 2 months of any implanted hormonal contraceptives including Mirena [progestin containing intrauterine system (IUS)] or Norplant (subdermal implant delivering LNG) NOTE: Removal of implanted hormonal contraceptives must have been for personal reasons unrelated to the purpose of enrollment in this study
- Current use of a non-hormone containing IUD. NOTE: Removal of an IUD must have been for personal reasons unrelated to the purpose of enrollment in this study
- Use of injectable contraceptives during the previous 3 months (e.g. Cyclofem) or 6 months (e.g. DMPA)
- Women who do not have at least two progesterone measurements during the control cycle of ≥10nmol/L will be excluded from further participation in the study (See Section 13.41)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Phase 2, Randomized Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914 on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women
The purpose of this study is to to determine pharmacodynamic effects of a vaginal ring delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on:
- follicular function and inhibition of ovulation
- the endometrium
- bleeding patterns; and also to assess safety including effects on the endometrium
- Conditions
- Contraception
- Being tested
- CDB-2914
- Keywords
- CDB-2914, Contraceptive Vaginal Rings, ovulation, endometrial changes, bleeding patterns, normal cycling women, Inhibition of ovulation, endometrial changes and bleeding patterns in normal cycling women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDB-2914Drug
Contraceptive Vaginal Rings delivering a daily dose of 1500 or 2500 μg of CDB-2914
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Contraceptive Vaginal Ring delivering a daily dose of 1500 μg of CDB-2914 Receives: Drug: CDB-2914 |
| 2 | Active comparator | Contraceptive Vaginal Ring delivering a daily dose of 2500 μg of CDB-2914 Receives: Drug: CDB-2914 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable will be ovulation suppression measured by progesterone serum levels.
Measured: All women will use the assigned CVR for 6 months
Secondary outcomes (2)
Regular follow-up of follicle diameter will be made with USS to determine the timing of ovulation or, in the absence of ovulation, the fate of the dominant follicle.
Measured: All women will use the assigned CVR for 6 months
Clinical safety will be evaluated and the effects on the endometrium will be measured.
Measured: All women will use the assigned CVR for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791297
- Sponsor's protocol ID
- Population Council #422
- Status last verified
- Aug 2017
- First submitted
- 13 Nov 2008
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914 on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women
- ClinicalTrials.gov ID
- NCT00791297
- Acronym / sponsor ID
- Population Council #422
- Conditions
- Contraception
- Keywords
- CDB-2914, Contraceptive Vaginal Rings, ovulation, endometrial changes, bleeding patterns, normal cycling women, Inhibition of ovulation, endometrial changes and bleeding patterns in normal cycling women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Nov 2008 (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 this study is to to determine pharmacodynamic effects of a vaginal ring delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on:
- follicular function and inhibition of ovulation
- the endometrium
- bleeding patterns; and also to assess safety including effects on the endometrium
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: CDB-2914Contraceptive Vaginal Ring delivering a daily dose of 1500 μg of CDB-2914 |
| 2 | Active comparator | Drug: CDB-2914Contraceptive Vaginal Ring delivering a daily dose of 2500 μg of CDB-2914 |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy women of reproductive age (21-40 years)
- Not at risk for pregnancy based on one of the following
- subject has undergone sterilization
- subject is monogamous and her male partner has undergone sterilization
- subject agrees to be abstinent for the entire duration of the study (Oregon site only)
Key exclusion criteria (42 listed)
- Women participating in another clinical trial
- Women not living in the catchment area of the clinic
- Known hypersensitivity to progestins or antiprogestins
- Known hypersensitivity to silicone rubber
- Any chronic disease
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-2914Contraceptive Vaginal Rings delivering a daily dose of 1500 or 2500 μg of CDB-2914 | Drug | 1, 2 |
Primary outcome
The primary efficacy variable will be ovulation suppression measured by progesterone serum levels.
Time frame: All women will use the assigned CVR for 6 months
2 secondary outcomes
Regular follow-up of follicle diameter will be made with USS to determine the timing of ovulation or, in the absence of ovulation, the fate of the dominant follicle.
Time frame: All women will use the assigned CVR for 6 months
Clinical safety will be evaluated and the effects on the endometrium will be measured.
Time frame: All women will use the assigned CVR for 6 months
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 15 Aug 2017.
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDB-2914 in people with Contraception, run by Population Council at 3 sites in 3 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 10 inclusion and 42 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 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, 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. 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?
The primary efficacy variable will be ovulation suppression measured by progesterone serum levels. (time frame: All women will use the assigned CVR for 6 months). 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 15 Aug 2017.