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

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ClinicalTrials.gov Identifier: NCT00915915
Recruitment Status : Completed
First Posted : June 8, 2009
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment Phase
Contraception Ovulation Inhibition Drug: Ethinylestradiol/Gestodene (BAY86-5016) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915915


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00915915     History of Changes
Other Study ID Numbers: 14348
2009-009177-10 ( EudraCT Number )
First Posted: June 8, 2009    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014

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
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Progestins
Contraceptives, Oral, Combined