CompletedPhase 2

Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control

United States123 participantsStarted 2007-09

Plain-language summary

Evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs).

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Ovulation Suppression in Three Treatment Groups Over 3 Cycles

Timeframe: 3 months

Cycle Control

Timeframe: 3 months

NCT IDNCT01250210

SponsorAgile Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-02

Results submitted2013-01-22

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.