CompletedNot Applicable

PROMES: A Clinical Study in Which Researchers Want to Learn More About the Safety Profile of MESIGYNA (Norethisterone Enantate 50 mg and Estradiol Valerate 5 mg) Used as a Medication to Prevent Pregnancy for Adult Women in Reproductive Age in the Peruvian Population at the Outpatient Clinic.

Peru296 participantsStarted 2019-08-26

Plain-language summary

Clinical study in which researchers want to learn more about the safety profile of MESIGYNA used as a medication in routine clinical practice to prevent pregnancy. In order to find this out researchers will collect historic and treatment related data during initial visit and follow-up visits of adult women in reproductive age in the Peruvian population at the outpatient clinic. Mesigyna is a combined injectable birth control medication (norethindrone ethanate (50 mg) and estradiol valerate (5 mg)) for women given monthly.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion Criteria: * Adult female patients,18 to 45 years old with a Mesigyna prescription * Women for whom the decision to initiate contraception with Mesigyna was made as per investigator's routine practice * Signed Informed Consent Exclusion Criteria: * Women participating in an investigational program with interventions outside of routine clinical practice * Hypersensitivity to norethisterone enantate or estradiol valerate

What they're measuring

Frequency of Adverse Events and Serious Adverse Events

Timeframe: Up to 6 months

Trial details

NCT IDNCT03901131

SponsorBayer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-08-31

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