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OpenTrials
Completed

NCT Number: NCT01204190

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

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.

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, State of Berlin, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gestodene/EE Patch (BAY86-5016)

Drug

0.55 mg ethinyl estradiol (EE) + 2.1 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days

Primary outcomes

  1. Hoogland score to evaluate the inhibition of ovulation

    Time frame: After 2 months

Secondary outcomes

  1. Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone

    Time frame: After 2 months

  2. Follicle size measured by transvaginal ultrasound examination

    Time frame: After 2 months

  3. Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)

    Time frame: After 2 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation During Treatment With Three Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol (EE) and 2.10 mg Gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 17, 2010
Registry last updated
Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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