CompletedPhase 2

Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.

Germany, Netherlands173 participantsStarted 2010-09

Plain-language summary

The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals. With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.

Who can participate

Age range18 Years – 35 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.

Inclusion Criteria: * Healthy female volunteers * age 18 - 35 years (smoker not older than 30 years, inclusive) * ovulatory pre-treatment cycle Exclusion Criteria: * Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease) * Regular intake of medication other than Oral Contraception * Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)

What they're measuring

Hoogland score to evaluate the inhibition of ovulation

Timeframe: After 2 months

Trial details

NCT IDNCT01204190

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-07

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