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
2 other identifiers
interventional
17
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2008
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 4, 2008
CompletedFirst Posted
Study publicly available on registry
August 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedDecember 2, 2014
November 1, 2014
6 months
August 4, 2008
November 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3.
4 month
Secondary Outcomes (5)
Assessment of ovarian activity during treatment cycle2 and 3 (Hoogland score)
4 month
Course of gonadotropins (FSH, LH, P, E2)
4 month
Endometrial thickness
4 month
Follicle size
4 month
Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3
4 month
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALInterventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (3)
Unknown Facility
Berlin, State of Berlin, 10115, Germany
Unknown Facility
Berlin, State of Berlin, 10707, Germany
Unknown Facility
Berlin, State of Berlin, 13342, Germany
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2008
First Posted
August 7, 2008
Study Start
August 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
December 2, 2014
Record last verified: 2014-11