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Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene

This study has been terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00729404
First received: August 4, 2008
Last updated: February 17, 2013
Last verified: February 2013
History of Changes
  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, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg EE and Either 1.05 or 2.1 mg GSD in Healthy Young Female Vol. Over a Period of 3 Treatment Cycles

Resource links provided by NLM:

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

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 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of ovarian activity during treatment cycle2 and 3 (Hoogland score) [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
  • Course of gonadotropins (FSH, LH, P, E2) [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
  • Endometrial thickness [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
  • Follicle size [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3 [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: August 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Ethinylestradiol/Gestodene (BAY86-5016)
transdermal patch: 0.55mg EE+2.1mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles)
Experimental: Arm 2 Drug: Ethinylestradiol/Gestodene (BAY86-5016)
transdermal patch: 0.55mg EE+1.05 mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles

Detailed Description:

Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.

  Eligibility

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

Inclusion Criteria:

  • Signed informed consent,
  • BMI: 18 - 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/arterial 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729404

Locations
Germany
Berlin, Germany, 10115
Berlin, Germany, 13342
Berlin, Germany, 10707
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00729404     History of Changes
Other Study ID Numbers: 91558, 2008-001198-13
Study First Received: August 4, 2008
Last Updated: February 17, 2013
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 May 21, 2013