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Completed

NCT Number: NCT00915915

Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)

Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers

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Key information

Conditions

Contraception Ovulation Inhibition

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, State of Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI: 18 BMI 30 kg/m²
  • Healthy female volunteers
  • Age 18-35 years (smoker not older than 30 years, inclusive)
  • Ovulatory pre-treatment cycle, at least 3 month since delivery
  • Abortion or lactation before the first screening examination
  • Willingness to use non-hormonal methods of contraception during entire study

Exclusion criteria

  • Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/artial thromboembolic disease
  • Regular intake of medication other than OCs
  • Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle

Treatment and study plan

Ethinylestradiol/Gestodene (BAY86-5016)

Drug

Transdermal patch: 0.55mg Ethinylestradiol (EE+2.1mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)

Primary outcomes

  1. The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3

    Time frame: 4 months

Secondary outcomes

  1. The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3

    Time frame: 4 months

  2. Course of gonadotropins (FSH, LH, P, E2)

    Time frame: 4 months

  3. Endometrial thickness and Follicle size

    Time frame: 4 months

  4. Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3

    Time frame: 4 Months

  5. Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3

    Time frame: 4 Months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol and Either 1.05 or 2.1 mg Gestodene in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 8, 2009
Registry last updated
Oct 28, 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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