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.

Completed

• Conditions: Contraceptive
• Interventions: Drug: Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)

• Registration Number: NCT03901131
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Study Start: 2019-08-26
• Primary Completion: 2021-08-31
• Study Completion: 2022-02-17
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 296

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

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Exclusion Criteria

• Women participating in an investigational program with interventions outside of routine clinical practice
• Hypersensitivity to norethisterone enantate or estradiol valerate

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAY98-7040	Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)	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.

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events and Serious Adverse Events	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
Number of injections	Up to 6 months
Frequency of injections	Up to 6 months
The number of injections	Up to 6 months
Comorbidities associated to greater incidence of AE and SAE	Up to 6 months	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.

Trial Locations

Locations (1)

Many locations; 🇵🇪 Multiple Locations, Peru