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
Overview
- Phase
- Phase 2
- Intervention
- levonorgestrel and ethinyl estradiol
- Conditions
- Ovulation Suppression
- Sponsor
- Agile Therapeutics
- Enrollment
- 123
- Primary Endpoint
- Ovulation Suppression in Three Treatment Groups Over 3 Cycles
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adult women, ages 18-
- •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.
Exclusion Criteria
- •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.
- •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.
Arms & Interventions
AG200-15
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.
Intervention: levonorgestrel and ethinyl estradiol
AG200
Drug intervention with levonorgestrel and ethinyl estradiol: AG200 a transdermal contraceptive system containing 2.17 mg of levonorgestrel and 1.92 of ethinyl estradiol.
Intervention: levonorgestrel and ethinyl estradiol
AG200LE
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.
Intervention: levonorgestrel and ethinyl estradiol
Outcomes
Primary Outcomes
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.