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Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00729404
First received: August 4, 2008
Last updated: November 27, 2014
Last verified: November 2014
August 4, 2008
November 27, 2014
August 2008
February 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00729404 on ClinicalTrials.gov Archive Site
  • Assessment of ovarian activity during treatment cycle2 and 3 (Hoogland score) [ Time Frame: 4 month ]
  • Course of gonadotropins (FSH, LH, P, E2) [ Time Frame: 4 month ]
  • Endometrial thickness [ Time Frame: 4 month ]
  • Follicle size [ Time Frame: 4 month ]
  • Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3 [ Time Frame: 4 month ]
Same as current
Not Provided
Not Provided
 
Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene
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
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
Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Contraception
  • Ovulation Inhibition
  • 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)
  • 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
  • Experimental: Arm 1
    Intervention: Drug: Ethinylestradiol/Gestodene (BAY86-5016)
  • Experimental: Arm 2
    Intervention: Drug: Ethinylestradiol/Gestodene (BAY86-5016)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
February 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00729404
91558
2008-001198-13 ( EudraCT Number )
No
Not Provided
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP