Clinical trial NCT01250210: Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovulation Suppression
Keywords: contraception
pregnancy prevention
Lead sponsor: Agile Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-11-30
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Healthy adult women, ages 18-45.
2. Cycles with a usual duration between 21 and 35 days and an individual variation of +/ 3 days.
3. Normotensive (blood pressure \< 140/90 mm Hg at rest) at screening and randomization visits (Visits 1 and 2).
4. Willing to use a non-hormonal method of contraception for the entire duration of the study, or
5. Have already undergone previous bilateral tubal ligation OR vasectomized partner OR not at risk of pregnancy.
6. Willing to refrain from excessive use of alcohol during the entire duration of the study.
7. Willing to give informed consent to participate in the study.

Exclusion Criteria:

1. History of significant medical illness or seizures.
2. Positive hepatitis B or C antibody or positive human immunodeficiency virus (HIV) antibody.
3. Known or suspected pregnancy.
4. A recent abnormal cervical smear - low-grade squamous intraepithelial lesion (SIL) or higher in the Bethesda System - which has not been resolved or treated.
5. 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.
6. Uncontrolled thyroid disorder.
7. History of or existing thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease.
8. Undiagnosed abnormal genital bleeding.
9. Known or suspected breast carcinoma, endometrial carcinoma, or estrogen-dependent neoplasia.
10. History or presence of dermal hypersensitivity in response to topical application.
11. Use of an injectable hormonal contraceptive (e.g. Depo-Provera®) within 6 months prior to Day 1.
12. Use of a contraceptive implant (e.g. Implanon® or Jadelle®) or hormone-medicated intrauterine device within 2 months (60 days) prior to Day 1.
13. Use of OCs or other sex steroid hormones within 60 days prior to Day 1.
14. Women who are breast-feeding or are within 2 months of stopping breast-feeding.
15. Status post-partum or post-abortion within a period of 2 months prior to Day 1.
16. 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.
17. Administration of investigational drug within 30 days prior to Day 1.
18. A history (within prior 12 months) of drug or alcohol abuse.
19. Women who smoke more than 4-5 cigarettes daily.
20. History of skin sensitivity to adhesives.
21. 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.

Primary outcomes:
measure: Ovulation Suppression in Three Treatment Groups Over 3 Cycles
timeFrame: 3 months
measure: Cycle Control
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Sandy Springs
country: United States
state: Georgia
city: Cary
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Jenkintown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Bristol
country: United States
state: Tennessee
Study officials:
affiliation: Agile Therapeutics
name: Elizabeth Garner, MD, MPH
role: STUDY_DIRECTOR
References: