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.

Bayer296 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

296

Conditions

Contraceptive

Interventions

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

Follow clinical administration

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Frequency of Adverse Events and Serious Adverse Events

Time frame: Up to 6 months

Secondary Outcomes

The number of injections

Time frame: Up to 6 months

Number of injections

Time frame: Up to 6 months

Frequency of injections

Time frame: Up to 6 months

Comorbidities associated to greater incidence of AE and SAE

The associated factors for AE for contraceptives are headaches, acne, obesity, hypertension, breast tenderness, dysmenorrhea, nausea. This could get worse with the use of contraceptives.

Time frame: Up to 6 months

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.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes