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Clinical Trials/EUCTR2007-004544-73-DE
EUCTR2007-004544-73-DE
Active, not recruiting
Not Applicable

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

Bayer Schering Pharma AG0 sitesNovember 12, 2007
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ConditionsThe trial will be performed in healthy female volunteers. The intended indication is female contraception.

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
The trial will be performed in healthy female volunteers. The intended indication is female contraception.
Sponsor
Bayer Schering Pharma AG
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 12, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Healthy female volunteer
  • •Age: 18 – 35 years (inclusive) at the first screening examination
  • •Willingness to use non\-hormonal methods of contraception during the entire study
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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