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.

Bayer

Status: Completed

Conditions: Contraceptive

Treatments: Drug: Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)

Study type: Observational

Funder types: Industry

Identifiers

NCT03901131

19243

Details and patient eligibility

About

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.

Enrollment: 296 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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 design

296 participants in 1 patient group

BAY98-7040

Description:

Female adult patients of reproductive age, who want to use a contraceptive method, will be enrolled after the investigator has made the decision for treatment with Mesigyna. Investigators should prescribe Mesigyna for medically approved indications as per the label of the medicine locally approved.

Treatment:

Drug: Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)