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: February 19, 2014
Last verified: February 2014

August 4, 2008
February 19, 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 ] [ Designated as safety issue: Yes ]
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 ] [ 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 ]
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
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
13
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
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00729404
91558, 2008-001198-13
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2014

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