check_circleStudy Completed

Contraception

Bayer Identifier:

15264

ClinicalTrials.gov Identifier:

NCT01204190

EudraCT Number:

2010-021255-81

EU CT Number:

Not Available
Investigation of three contraceptive hormone patches in regard to inhibition of ovulation following application over 3 treatment cycles in healthy, young women.

Trial purpose

The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals.
With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Healthy female volunteers
    - age 18 – 35 years (smoker not older than 30 years, inclusive)
    - ovulatory pre-treatment cycle
  • - Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease)
    - Regular intake of medication other than Oral Contraception
    - Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)

Trial summary

Enrollment Goal
173
Trial Dates
September 2010 - August 2011
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
Dinox B.V.Groningen, 9713 GZ, Netherlands

Primary Outcome

  • Hoogland score to evaluate the inhibition of ovulation
    date_rangeTime Frame:
    After 2 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone
    date_rangeTime Frame:
    After 2 months
    enhanced_encryption
    Safety Issue:
    No
  • Follicle size measured by transvaginal ultrasound examination
    date_rangeTime Frame:
    After 2 months
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)
    date_rangeTime Frame:
    After 2 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Multicenter, open-label, randomized study to evaluate inhibition of ovulation during treatment with three transdermal patch formulations containing 0.55 mg ethinylestradiol (EE) and 2.10 mg gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in healthy young female volunteers over a period of 3 treatment cycles
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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