Ovulation SuppressionPhase 2NCT01250210
Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control
A Phase 2 study testing levonorgestrel and ethinyl estradiol in people with Ovulation Suppression, run by Agile Therapeutics at 11 sites in United States.
Trial summary
Evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovulation Suppression
- What is being tested?
- levonorgestrel and ethinyl estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 11 sitesUnited States
- Study dates
- Sep 2007to Feb 2008
- Phase
- Phase 2
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult women, ages 18-45.
- Cycles with a usual duration between 21 and 35 days and an individual variation of +/ 3 days.
- Normotensive (blood pressure < 140/90 mm Hg at rest) at screening and randomization visits (Visits 1 and 2).
- Willing to use a non-hormonal method of contraception for the entire duration of the study, or
- Have already undergone previous bilateral tubal ligation OR vasectomized partner OR not at risk of pregnancy.
- Willing to refrain from excessive use of alcohol during the entire duration of the study.
- Willing to give informed consent to participate in the study.
Who cannot join
- History of significant medical illness or seizures.
- Positive hepatitis B or C antibody or positive human immunodeficiency virus (HIV) antibody.
- Known or suspected pregnancy.
- A recent abnormal cervical smear - low-grade squamous intraepithelial lesion (SIL) or higher in the Bethesda System - which has not been resolved or treated.
- Any disorder that contraindicates the use of contraceptive steroids i.e., history of heart attack and stroke, blood clots in the legs, lungs or eyes, history of blood clots in the deep veins of the legs, known or suspected breast cancer, hepatitis or yellowing of the whites of the eyes or the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives, headaches with neurological symptoms, disease of heart valves with complications.
- Uncontrolled thyroid disorder.
Show all 21Show fewer
- History of or existing thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease.
- Undiagnosed abnormal genital bleeding.
- Known or suspected breast carcinoma, endometrial carcinoma, or estrogen-dependent neoplasia.
- History or presence of dermal hypersensitivity in response to topical application.
- Use of an injectable hormonal contraceptive (e.g. Depo-Provera®) within 6 months prior to Day 1.
- Use of a contraceptive implant (e.g. Implanon® or Jadelle®) or hormone-medicated intrauterine device within 2 months (60 days) prior to Day 1.
- Use of OCs or other sex steroid hormones within 60 days prior to Day 1.
- Women who are breast-feeding or are within 2 months of stopping breast-feeding.
- Status post-partum or post-abortion within a period of 2 months prior to Day 1.
- Chronic use of any medication that might interfere with the metabolism of hormone contraceptives (e.g., rifampin, barbiturates, phenytoin, primidone, topiramate, carbamazepine, phenylbutazone, ritonavir, modafinil, St John's Wort etc.) or use within the past 3 months prior to Day 1.
- Administration of investigational drug within 30 days prior to Day 1.
- A history (within prior 12 months) of drug or alcohol abuse.
- Women who smoke more than 4-5 cigarettes daily.
- History of skin sensitivity to adhesives.
- Use of over-the-counter medications or herbals that might interfere with the metabolism of hormone contraceptives within 3 days prior to wearing the first patch.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Bristol, Tennessee, 37620
Study site
Cary, North Carolina, 27518
Study site
Denver, Colorado, 80218
Study site
Jenkintown, Pennsylvania, 19046
Study site
Pembroke Pines, Florida, 33026
Study site
Philadelphia, Pennsylvania, 19114
Study site
San Diego, California, 92108
Study site
Sandy Springs, Georgia, 30328
Study site
Tampa, Florida, 33607
Study site
Tucson, Arizona, 85712
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: Evaluation of Pharmacodynamic Effects on Ovulation Suppression and Cycle Control of Three Agile Contraceptive Patches Containing Different Doses of Ethinyl Estradiol(EE)During Three Cycles of Administration
Evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs).
Read the detailed description
The primary objective was to evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs) containing 2 different doses of levonorgestrel (LNG) and 3 different doses of ethinyl estradiol (EE) during 3 consecutive cycles of administration of each treatment.
- Conditions
- Ovulation Suppression
- Being tested
- levonorgestrel and ethinyl estradiol
- Keywords
- contraception, pregnancy prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levonorgestrel and ethinyl estradiolDrug
Also called contraception, hormonal contraception, transdermal
pregnancy prevention
| Study group | Role | What they receive |
|---|---|---|
| AG200-15 | Experimental | Drug intervention with levonorgestrel and ethinyl estradiol : AG200-15 a transdermal contraceptive system containing 2.60 mg of levonorgestrel and 2.30 mg of ethinyl estradiol. Receives: Drug: levonorgestrel and ethinyl estradiol |
| AG200 | Experimental | Drug intervention with levonorgestrel and ethinyl estradiol: AG200 a transdermal contraceptive system containing 2.17 mg of levonorgestrel and 1.92 of ethinyl estradiol. Receives: Drug: levonorgestrel and ethinyl estradiol |
| AG200LE | Experimental | Drug intervention with levonorgestrel and ethinyl estradiol: AG200LE a transdermal contraceptive system containing 2.17 mg of levonorgestrel and 1.28 mg of ethinyl estradiol. Receives: Drug: levonorgestrel and ethinyl estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation Suppression in Three Treatment Groups Over 3 Cycles
Ovulation suppression measured by possible ovulation. Possible ovulation is defined as cycles with greatest progesterone level ≥4.7 ng/mL across Cycles 1-3 combined for each Arm/Group. The following four primary analysis datasets are:
Intent-to-treat (ITT): At least 1 study patch was applied and at least 1 progesterone measurement is available at 1 of the nominal data collection points.
Complete progesterone: At least 1 study patch was applied and at least 3 progesterone measurements are available across any of the data collection points.
Perfect compliance: If no patch has been off >1 day and no more than 1 day has elapsed between patch changes.
Verifiable compliance: is a cycle during which at least 1 study patch was applied and where LNG and EE measurements were available at each of the nominal data collection points of Days 8, 15, and 22, and all values were above the lower detection limit.
Measured: 3 months
Cycle Control
The incidence of breakthrough bleeding (BTB) and/or spotting (S) episodes in Cycle 3 for ITT cycles. A BTB/S episode was defined as any number of days with BTB and/or BTS preceded and followed by at least 2 bleeding-free days.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- Other trials for Ovulation SuppressionStudies 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agile Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Garner, MD, MPH, Study director, Agile Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250210
- Sponsor's protocol ID
- ATI-CL11
- Status last verified
- Jul 2018
- First submitted
- 29 Nov 2010
- Last updated
- 5 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacodynamic Effects on Ovulation Suppression and Cycle Control of Three Agile Contraceptive Patches Containing Different Doses of Ethinyl Estradiol(EE)During Three Cycles of Administration
- ClinicalTrials.gov ID
- NCT01250210
- Acronym / sponsor ID
- ATI-CL11
- Conditions
- Ovulation Suppression
- Keywords
- contraception, pregnancy prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Agile TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Posted 5 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs).
Detailed description
The primary objective was to evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs) containing 2 different doses of levonorgestrel (LNG) and 3 different doses of ethinyl estradiol (EE) during 3 consecutive cycles of administration of each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AG200-15 | Experimental | Drug: levonorgestrel and ethinyl estradiolDrug intervention with levonorgestrel and ethinyl estradiol : AG200-15 a transdermal contraceptive system containing 2.60 mg of levonorgestrel and 2.30 mg of ethinyl estradiol. |
| AG200 | Experimental | Drug: levonorgestrel and ethinyl estradiolDrug intervention with levonorgestrel and ethinyl estradiol: AG200 a transdermal contraceptive system containing 2.17 mg of levonorgestrel and 1.92 of ethinyl estradiol. |
| AG200LE | Experimental | Drug: levonorgestrel and ethinyl estradiolDrug intervention with levonorgestrel and ethinyl estradiol: AG200LE a transdermal contraceptive system containing 2.17 mg of levonorgestrel and 1.28 mg of ethinyl estradiol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult women, ages 18-45.
- Cycles with a usual duration between 21 and 35 days and an individual variation of +/ 3 days.
- Normotensive (blood pressure < 140/90 mm Hg at rest) at screening and randomization visits (Visits 1 and 2).
- Willing to use a non-hormonal method of contraception for the entire duration of the study, or
- Have already undergone previous bilateral tubal ligation OR vasectomized partner OR not at risk of pregnancy.
Key exclusion criteria (21 listed)
- History of significant medical illness or seizures.
- Positive hepatitis B or C antibody or positive human immunodeficiency virus (HIV) antibody.
- Known or suspected pregnancy.
- A recent abnormal cervical smear - low-grade squamous intraepithelial lesion (SIL) or higher in the Bethesda System - which has not been resolved or treated.
- Any disorder that contraindicates the use of contraceptive steroids i.e., history of heart attack and stroke, blood clots in the legs, lungs or eyes, history of blood clots in the deep veins of the legs, known or suspected breast cancer, hepatitis or yellowing of the whites of the eyes or the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives, headaches with neurological symptoms, disease of heart valves with complications.
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 |
|---|---|---|
| levonorgestrel and ethinyl estradiolAlso: contraception, hormonal contraception, transdermalpregnancy prevention | Drug | AG200, AG200-15, AG200LE |
Primary outcome
Ovulation Suppression in Three Treatment Groups Over 3 Cycles
Time frame: 3 months
Ovulation suppression measured by possible ovulation. Possible ovulation is defined as cycles with greatest progesterone level ≥4.7 ng/mL across Cycles 1-3 combined for each Arm/Group. The following four primary analysis datasets are: Intent-to-treat (ITT): At least 1 study patch was applied and at least 1 progesterone measurement is available at 1 of the nominal data collection points. Complete progesterone: At least 1 study patch was applied and at least 3 progesterone measurements are available across any of the data collection points. Perfect compliance: If no patch has been off >1 day and no more than 1 day has elapsed between patch changes. Verifiable compliance: is a cycle during which at least 1 study patch was applied and where LNG and EE measurements were available at each of the nominal data collection points of Days 8, 15, and 22, and all values were above the lower detection limit.
Cycle Control
Time frame: 3 months
The incidence of breakthrough bleeding (BTB) and/or spotting (S) episodes in Cycle 3 for ITT cycles. A BTB/S episode was defined as any number of days with BTB and/or BTS preceded and followed by at least 2 bleeding-free days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elizabeth Garner, MD, MPH study director
Agile Therapeutics
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing levonorgestrel and ethinyl estradiol in people with Ovulation Suppression, run by Agile Therapeutics at 11 sites in United States.
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 7 inclusion and 21 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 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
Yes. Results are posted in the registry (first posted 5 Jul 2018). 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?
Ovulation Suppression in Three Treatment Groups Over 3 Cycles (time frame: 3 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?
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 5 Jul 2018.