Pregnancy PreventionPhase 4NCT00570440
Continuous Use of COCs
A Phase 4 study testing Oral contraceptives--ethinyl estradiol, levonorgestrel in people with Pregnancy Prevention, run by FHI 360 at 2 sites in 2 countries.
Trial summary
The primary objective is to determine if continuous COC use leads to higher continuation rates over 12 months of follow up than use of the standard 28-day COC regimen. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Prevention
- What is being tested?
- Oral contraceptives--ethinyl estradiol, levonorgestrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2007to Oct 2010
- Phase
- Phase 4
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-30
- Currently has menstrual periods every 21-35 days
- Willing and able to be randomly assigned to one of the two study groups and to comply with all study requirements
- Has signed the informed consent form
- Has a negative urine pregnancy test at enrollment
Who cannot join
- Has contraindications to COC use (see WHO MEC-3rd edition)
- Is in any other research study
- Has been pregnant in the past 3 months
- Is breastfeeding or has breastfed in the past 3 months
- Is currently using an IUD (women who agree to IUD removal are eligible once the IUD is removed)
- Has had an injection of DMPA in the past 6 months
Show all 12Show fewer
- Has had an injection of NET-EN in the past 3 months
- Has used combined injectables, oral contraceptive pills, implants, or a hormonal IUD in the past 2 months
- Has had any of the following conditions since her last pregnancy, or since menarche if never pregnant:
- Pelvic infection treated with antibiotics
- Diagnosis of infertility
- Endometriosis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Dominican Republic1 site
PROFAMILIA - Santo Domingo, Dominican Republic
Ens. Luperon, Santo Domingo Province
Nicaragua1 site
PROFAMILIA - Managua, Nicaragua
Managua, Managua Department
About this study
Official title: Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills
The primary objective is to determine if continuous COC use leads to higher continuation rates over 12 months of follow up than use of the standard 28-day COC regimen.
Read the detailed description
Family Health International has recently initiated a USAID funded study to investigate the pregnancy rates, continuation rates, and acceptability of COCs in women taking COCs by the 21/7 cyclic regimen compared with the continuous use of COCs with bleeding-signaled hormone-free intervals. The primary objective is to determine whether continuous COC use leads to higher 12-month continuation rates than use of the standard 28-day COC regimen. Secondary objectives are to 1) compare pregnancy probabilities through 6 and 12 months between the continuous use group and the 28-day group 2) compare COC continuation rates through 6 months between the continuous use group and the 28-day group 3) compare acceptability of the two COC regimens 4) to compare bleeding and other side effects between the continuous use group and the 28-day group 5) to compare hemoglobin/hematocrit between the continuous use group and the 28-day group
- Conditions
- Pregnancy Prevention
- Being tested
- Oral contraceptives--ethinyl estradiol, levonorgestrel
- Keywords
- AE adverse event, AIDS acquired immunodeficiency syndrome, ALT (SGPT) alanine aminotransferase, ART antiretroviral therapy, AST (SGOT) aspartate aminotransferase, DCF data collection forms, DMC Data Monitoring Committee, FDA (U.S.) Food and Drug Administration, GCP Good Clinical Practice guidelines, HB sAg Hepatitis B surface antigen, ICH International Conference of Harmonisation, IND Investigational New Drug Application, IRB Institutional Review Board, IU international units, mg milligram(s), mm3 cubic millimeter(s), PCR polymerase chain reaction, SAE serious adverse event, µg microgram, ULN upper limit of the normal range
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral contraceptives--ethinyl estradiol, levonorgestrelDrug
3 visits - screening/enrollment, 6-months and 12 months
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel |
| B | Active comparator | Not described Receives: Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 month cumulative COC discontinuation probabilities
Measured: 12 months
Secondary outcomes (1)
Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2010
- Study completionOct 2010
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 Pregnancy PreventionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)
- Responsible party
- Sponsor
- Investigators
- Kavita Nanda, MD, MHS, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570440
- Sponsor's protocol ID
- 9964
- Status last verified
- Oct 2011
- First submitted
- 10 Dec 2007
- Last updated
- 31 Oct 2011
- Results posted
- No
Publications
Nanda K, Lendvay A, Kwok C, Tolley E, Dube K, Brache V. Continuous compared with cyclic use of oral contraceptive pills in the Dominican Republic: a randomized controlled trial. Obstet Gynecol. 2014 May;123(5):1012-1022. doi: 10.1097/AOG.0000000000000235.
PubMed 24785854
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Cyclic Use of Combined Oral Contraceptive Pills
- ClinicalTrials.gov ID
- NCT00570440
- Acronym / sponsor ID
- 9964
- Conditions
- Pregnancy Prevention
- Keywords
- AE adverse event, AIDS acquired immunodeficiency syndrome, ALT (SGPT) alanine aminotransferase, ART antiretroviral therapy, AST (SGOT) aspartate aminotransferase, DCF data collection forms, DMC Data Monitoring Committee, FDA (U.S.) Food and Drug Administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- La Asociación Pro Bienestar de la Familia de Guatemala (APROFAM)
- Study start
- Aug 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Dec 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 primary objective is to determine if continuous COC use leads to higher continuation rates over 12 months of follow up than use of the standard 28-day COC regimen.
Detailed description
Family Health International has recently initiated a USAID funded study to investigate the pregnancy rates, continuation rates, and acceptability of COCs in women taking COCs by the 21/7 cyclic regimen compared with the continuous use of COCs with bleeding-signaled hormone-free intervals. The primary objective is to determine whether continuous COC use leads to higher 12-month continuation rates than use of the standard 28-day COC regimen. Secondary objectives are to 1) compare pregnancy probabilities through 6 and 12 months between the continuous use group and the 28-day group 2) compare COC continuation rates through 6 months between the continuous use group and the 28-day group 3) compare acceptability of the two COC regimens 4) to compare bleeding and other side effects between the continuous use group and the 28-day group 5) to compare hemoglobin/hematocrit between the continuous use group and the 28-day group
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel |
| B | Active comparator | Drug: Oral contraceptives--ethinyl estradiol, levonorgestrel |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-30
- Currently has menstrual periods every 21-35 days
- Willing and able to be randomly assigned to one of the two study groups and to comply with all study requirements
- Has signed the informed consent form
- Has a negative urine pregnancy test at enrollment
Key exclusion criteria (12 listed)
- Has contraindications to COC use (see WHO MEC-3rd edition)
- Is in any other research study
- Has been pregnant in the past 3 months
- Is breastfeeding or has breastfed in the past 3 months
- Is currently using an IUD (women who agree to IUD removal are eligible once the IUD is removed)
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 |
|---|---|---|
| Oral contraceptives--ethinyl estradiol, levonorgestrel3 visits - screening/enrollment, 6-months and 12 months | Drug | A, B |
Primary outcome
12 month cumulative COC discontinuation probabilities
Time frame: 12 months
1 secondary outcome
Pregnancy rates through 6 and 12 months; 6 month cumulative discontinuation probabilities; acceptability; bleeding and other side effects; hemoglobin/hematocrit
Time frame: 12 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 31 Oct 2011.
- Derived from this study: PubMed 24785854Nanda K, Lendvay A, Kwok C, Tolley E, Dube K, Brache V. Continuous compared with cyclic use of oral contraceptive pills in the Dominican Republic: a randomized controlled trial. Obstet Gynecol. 2014 May;123(5):1012-1022. doi: 10.1097/AOG.0000000000000235.
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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.
Kavita Nanda, MD, MHS principal investigator
FHI 360
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral contraceptives--ethinyl estradiol, levonorgestrel in people with Pregnancy Prevention, run by FHI 360 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 5 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 31 Oct 2011. 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 Dominican Republic, Nicaragua. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
12 month cumulative COC discontinuation probabilities (time frame: 12 months). 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 NCT00570440, 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 31 Oct 2011.