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.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Contraceptive

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BAY98-7040<br>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. | Drug: Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)<br>* Follow clinical administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Events and Serious Adverse Events |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of injections |  | Up to 6 months | 
| Number of injections |  | Up to 6 months | 
| Frequency of injections |  | 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. | Up to 6 months |