Trial Condition(s):

Contraceptive

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. (PROMES)

Bayer Identifier:

19243

ClinicalTrials.gov Identifier:

NCT03901131

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
296
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Mesigyna (Norethisterone enantate/estradiol valerate, BAY98-7040)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Peru

Status
Completed
 

Trial Design