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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00915915
First received: May 18, 2009
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Contraception
Ovulation Inhibition
Drug: Ethinylestradiol/Gestodene (BAY86-5016)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Course of gonadotropins (FSH, LH, P, E2) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Endometrial thickness and Follicle size [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3 [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: June 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Ethinylestradiol/Gestodene (BAY86-5016)
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)
Experimental: Arm 2 Drug: Ethinylestradiol/Gestodene (BAY86-5016)
Transdermal patch: 0.55mg Ethinylestradiol (EE+1.05mg 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)

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915915

Locations
Germany
Berlin, Germany, 10115
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00915915     History of Changes
Other Study ID Numbers: 14348, 2009-009177-10
Study First Received: May 18, 2009
Last Updated: June 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Female contraception
Ovulation inhibition

Additional relevant MeSH terms:
Ethinyl Estradiol
Gestodene
Femovan
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Combined
Progestins

ClinicalTrials.gov processed this record on July 22, 2014