NCT03901131

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: PROspective, Non-Interventional, Observational, Longitudinal Study to Describe the Safety Profile of MESIGYNA® (Norethisterone Enantate 50 mg and Estradiol Valerate 5 mg) as a Contraceptive Method for Women in Reproductive Age at the Outpatient Clinic

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 296 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Contraceptive

Interventions

Type	Name	Description
DRUG	Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)	Follow clinical administration

Timeline

• Start date: 2019-08-26
• Primary completion: 2021-08-31
• Completion: 2022-02-17
• First posted: 2019-04-03
• Last updated: 2022-12-21

Locations

1 site across 1 country: Peru