HealthyPhase 3NCT00922233
Pericoital Oral Contraception With Levonorgestrel
A Phase 3 study testing levonorgestrel in people with Healthy, run by FHI 360 at 4 sites in 2 countries.
Trial summary
A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel Read more about this study
- Who is it for?
- Ages Up to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- levonorgestrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2010to Nov 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Each woman enrolled in the trial must meet the following inclusion criteria:
- Competent to provide informed consent to participate in the trial and has done so.
- At least the minimum age is 18 to 45 years old.
- Had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months.
- At low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following:
- More than one sexual partner currently or any expectation of having more than one sexual partner in the next 6.5 months
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- Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
- Treatment for a STI within the past 6 months, excluding recurrent genital herpes or condyloma
- Sharing of illicit injection drug equipment ever in the past.
- Willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs).
- Wants to avoid pregnancy for at least the next 6.5 months.
- Willing to accept an uncertain risk of pregnancy during the study.
- Gives correct answers to the informed consent quiz.
- Willing and able to follow all study requirements.
Who cannot join
- To be eligible for enrollment, a woman must not meet any of the following exclusion criteria:
- Pregnant as verified by a pregnancy test at enrollment.
- Has an indication of current subfecundity, specifically:
- Her last pregnancy ended within the last 8 weeks, or she has had fewer than two menstrual periods since resolution of last pregnancy
- She has not had normal monthly menses for the past 2 months
- She is currently breastfeeding
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- She has used any hormonal contraceptive other than emergency contraceptive pills since the onset of her last menstrual period
- Has received an injection of a long term injectable contraceptive in the last 9 months
- Currently has an intrauterine device
- Has had a sterilization procedure or ectopic pregnancy
- Has been diagnosed by a clinician as having a fertility problem
- Her partner has had a sterilization procedure or infertility diagnosis, to her knowledge.
- She currently has known contraindications to progestin-only pills, specifically including the following conditions:
- Unexplained abnormal vaginal bleeding
- Deep venous thrombosis or pulmonary embolus
- Active viral hepatitis
- Decompensated cirrhosis
- Liver tumor
- History of breast cancer within the past 5 years.
- Has a breast mass on examination.
- Has a personal or family history suggestive of predisposition to thrombosis.
- Has a serious contraindication to pregnancy (medical condition or use of chronic medication such as isotretinoin or thalidomide).
- Taking drugs that are known to interact with progestins (such as rifampicin or anticonvulsant medications).
- Has previously participated in this study.
- Currently participating in another medical research study.
- The site investigator or designee perceives another reason to exclude her from the trial.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Planned Parenthood of the Rocky Mountains
Denver, Colorado, 80232
Planned Parenthood Gulf Coast, Inc.
Houston, Texas, 77004
Planned Parenthood Association of Utah
Salt Lake City, Utah, 84102
About this study
Official title: Pericoital Oral Contraception With Levonorgestrel: A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Acceptability
A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel
Read the detailed description
This is a prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel (LNG). The objectives of the study as stated in the study protocol are as follows:
- To evaluate the efficacy of the study regimen among women who have sex 1-4 days a month and who are relying on the study regimen as their primary method of contraception
- To evaluate the safety of this regimen, with particular emphasis on its effects on vaginal bleeding patterns and anemia
- To evaluate the acceptability of the regimen The study will enroll fertile women of reproductive age who have sex up to 6 days a month, are at low risk for sexually transmitted infections (STIs), have no contraindications to progestin-only oral contraceptives,have no serious contraindications to pregnancy, and are willing to use an investigational method of contraception as their only contraceptive method for 6.5 months (each tablet contains 0.75 mg LNG to be used after every sex act).
- Conditions
- Healthy
- Being tested
- levonorgestrel
- Keywords
- Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levonorgestrelDrug
oral contraceptive pills
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel | Experimental | 0.75 mg of levonorgestrel within 24 hours of sex Receives: Drug: levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35)
Participants were followed for 6.5 months.Pearl Index in the 18-35 year population was collected excluding months in which barrier methods, condoms, or emergency contraception were used unless the subject conceived
Measured: 6.5 months
Participant Report of Adverse Events.
Safety data includes data from each subject up to two weeks after her last use of the study tablets as well as all events deemed related to study product, regardless of date last tablet was taken
Measured: 6.5 months
Secondary outcomes (1)
Acceptability Based on Bleeding Patterns Reported
Number of participants who reported bleeding patterns were acceptable and would therefore use Levonorgestrel
Measured: 6.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vera Halpern, MD, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922233
- Sponsor's protocol ID
- 10139
- Status last verified
- Aug 2013
- First submitted
- 10 Jun 2009
- Last updated
- 29 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Taylor DJ, Lendvay A, Halpern V, Bahamondes LG, Fine PM, Ginde SY, Wheeless A, Raymond EG. A single-arm study to evaluate the efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel. Contraception. 2014 Mar;89(3):215-21. doi: 10.1016/j.contraception.2013.11.013. Epub 2013 Nov 26.
PubMed 24388695
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericoital Oral Contraception With Levonorgestrel: A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Acceptability
- ClinicalTrials.gov ID
- NCT00922233
- Acronym / sponsor ID
- 10139
- Conditions
- Healthy
- Keywords
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Posted 29 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel
Detailed description
This is a prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel (LNG). The objectives of the study as stated in the study protocol are as follows:
- To evaluate the efficacy of the study regimen among women who have sex 1-4 days a month and who are relying on the study regimen as their primary method of contraception
- To evaluate the safety of this regimen, with particular emphasis on its effects on vaginal bleeding patterns and anemia
- To evaluate the acceptability of the regimen The study will enroll fertile women of reproductive age who have sex up to 6 days a month, are at low risk for sexually transmitted infections (STIs), have no contraindications to progestin-only oral contraceptives,have no serious contraindications to pregnancy, and are willing to use an investigational method of contraception as their only contraceptive method for 6.5 months (each tablet contains 0.75 mg LNG to be used after every sex act).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel | Experimental | Drug: levonorgestrel0.75 mg of levonorgestrel within 24 hours of sex |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Competent to provide informed consent to participate in the trial and has done so.
- At least the minimum age is 18 to 45 years old.
- Had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months.
- At low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following:
- Willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs).
Key exclusion criteria (26 listed)
- To be eligible for enrollment, a woman must not meet any of the following exclusion criteria:
- Pregnant as verified by a pregnancy test at enrollment.
- Has an indication of current subfecundity, specifically:
- She currently has known contraindications to progestin-only pills, specifically including the following conditions:
- Has a breast mass on examination.
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 |
|---|---|---|
| levonorgestreloral contraceptive pills | Drug | Levonorgestrel |
Primary outcome
Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35)
Time frame: 6.5 months
Participants were followed for 6.5 months.Pearl Index in the 18-35 year population was collected excluding months in which barrier methods, condoms, or emergency contraception were used unless the subject conceived
Participant Report of Adverse Events.
Time frame: 6.5 months
Safety data includes data from each subject up to two weeks after her last use of the study tablets as well as all events deemed related to study product, regardless of date last tablet was taken
1 secondary outcome
Acceptability Based on Bleeding Patterns Reported
Time frame: 6.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24388695Taylor DJ, Lendvay A, Halpern V, Bahamondes LG, Fine PM, Ginde SY, Wheeless A, Raymond EG. A single-arm study to evaluate the efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel. Contraception. 2014 Mar;89(3):215-21. doi: 10.1016/j.contraception.2013.11.013. Epub 2013 Nov 26.
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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.
Vera Halpern, MD principal investigator
FHI 360
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing levonorgestrel in people with Healthy, run by FHI 360 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 14 inclusion and 26 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 29 Oct 2013. 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 United States, Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35) (time frame: 6.5 months). The study lists 2 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 NCT00922233, 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 29 Oct 2013.