check_circleStudy Completed

Contraception

Bayer Identifier:

91697

ClinicalTrials.gov Identifier:

NCT00631124

EudraCT Number:

2007-004544-73

EU CT Number:

Not Available
A study to evaluate inhibition of ovulation of two oral estrogen/progestogen regimens in healthy, young females over a period of 3 treatment cycles

Trial purpose

Investigation of a new pill containing an estrogen and a progestin in order to monitor the inhibition of the ovulation in young healthy females over 3 treatment cycles

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Healthy female volunteers,
    - Age 18 - 35 years
  • - Contraindications for use of a combined (estrogen/progestogen) contraceptive (e.g. history of venous/arterial thromboembolic disease)
    - Regular intake of medication
    - Clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
    - Anovulatory pre-treatment cycle

Trial summary

Enrollment Goal
103
Trial Dates
February 2008 - December 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
E2/DRSP (BAY86-4891)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Bayer Pharma AGBerlin, 13353, Germany
Completed
Dinox GmbH BerlinBerlin, 10115, 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, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Assessment of ovarian activity in treatment cycles 2 and 3
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    no
  • Course of gonadotropins (FSH, LH)
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    no
  • Endometrial growth
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    no
  • Pharmacokinetics of estrogen and progestin in treatment cycle 3
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    no

Trial design

A double-blind, randomized, uncontrolled study to evaluate inhibition of ovulation of two oral estradiol / drospirenone regimens in healthy young female volunteers over a period of 3 treatment cycles
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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