stop_circleTerminated/Withdrawn

Contraception, Ovulation Inhibition

Bayer Identifier:

91558

ClinicalTrials.gov Identifier:

NCT00729404

EudraCT Number:

2008-001198-13

EU CT Number:

Not Available
Inhibition of ovulation, patch, ethinylestradiol and gestodene

Trial 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

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
17
Trial Dates
August 2008 - February 2009
Phase
Phase 2
Could I Receive a placebo
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Terminated
Dinox GmbH BerlinBerlin, 10115, Germany
Terminated
Bayer Schering Pharma AG - Clin. Pharm. BerlinBerlin, 13342, Germany
Terminated
Landesamt für Gesundheit und SozialesBerlin, 10707, Germany

Primary Outcome

  • The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3.
    date_rangeTime Frame:
    4 month
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Assessment of ovarian activity during treatment cycle2 and 3 (Hoogland score)
    date_rangeTime Frame:
    4 month
    enhanced_encryption
    Safety Issue:
    yes
  • Course of gonadotropins (FSH, LH, P, E2)
    date_rangeTime Frame:
    4 month
    enhanced_encryption
    Safety Issue:
    yes
  • Endometrial thickness
    date_rangeTime Frame:
    4 month
    enhanced_encryption
    Safety Issue:
    yes
  • Follicle size
    date_rangeTime Frame:
    4 month
    enhanced_encryption
    Safety Issue:
    yes
  • Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3
    date_rangeTime Frame:
    4 month
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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