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Clinical Trials/NL-OMON27454
NL-OMON27454
Completed
Not Applicable

A dose finding study to assess the contraceptive efficacy and the effect on liver function of estetrol by daily oral administration to healthy female volunteers.

Estetra S.A.mw. X.Y. Zimmermanp/a Postbus 4643700 AL ZeistTel: +31 30 6 985 020Fax: +31 30 6 985 021yz@pantarheibio.com0 sites100 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Estetra S.A.mw. X.Y. Zimmermanp/a Postbus 4643700 AL ZeistTel: +31 30 6 985 020Fax: +31 30 6 985 021yz@pantarheibio.com
Enrollment
100
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

/A

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Estetra S.A.mw. X.Y. Zimmermanp/a Postbus 4643700 AL ZeistTel: +31 30 6 985 020Fax: +31 30 6 985 021yz@pantarheibio.com

Eligibility Criteria

Inclusion Criteria

  • 1\. At least 18 years and not older than 35 years of age;
  • 2\. Willing to use a barrier method of contraception during wash\-out;

Exclusion Criteria

  • 1\. Clinically significant abnormal results of routine haematology, serum biocemistry, urinalysis and/or ECG;
  • 2\. Women with a washout cycle with a duration of more than 42 days;

Outcomes

Primary Outcomes

Not specified

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