check_circleStudy Completed

Contraception, Ovulation inhibition

Bayer Identifier:

14348

ClinicalTrials.gov Identifier:

NCT00915915

EudraCT Number:

2009-009177-10

EU CT Number:

Not Available
Inhibition of ovulation and pharmacokinetics of transdermal ethinylestradiol (EE) and Gestodene (GSD)

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
  • - BMI: 18 BMI 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/artial 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
108
Trial Dates
June 2009 - April 2010
Phase
Phase 2
Could I Receive a placebo
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Dinox GmbH BerlinBerlin, 10115, Germany
Completed
Bayer Schering Pharma AGBerlin, 13353, 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 months
    enhanced_encryption
    Safety Issue:
    yes

Secondary 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 months
    enhanced_encryption
    Safety Issue:
    yes
  • Course of gonadotropins (FSH, LH, P, E2)
    date_rangeTime Frame:
    4 months
    enhanced_encryption
    Safety Issue:
    yes
  • Endometrial thickness and Follicle size
    date_rangeTime Frame:
    4 months
    enhanced_encryption
    Safety Issue:
    yes
  • Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3
    date_rangeTime Frame:
    4 Months
    enhanced_encryption
    Safety Issue:
    yes
  • Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3
    date_rangeTime Frame:
    4 Months
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Multicenter, open-label, randomized study to evaluate inhibition of ovulation of two transdermal patch formulations containing 0.55 mg ethinylestradiol and either 1.05 or 2.1 mg gestodene in healthy young female volunteers 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

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe