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.

Contraceptive Clinical Trial

— PROMES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901131
• Other study ID #: 19243
• Status: Completed
• Start date: August 26, 2019
• Est. completion date: February 17, 2022

Study information

• Verified date: December 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: February 17, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraceptive

Intervention

Drug:
• Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)
Follow clinical administration

Locations

Country	Name	City	State
Peru	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Adverse Events and Serious Adverse Events		Up to 6 months
Secondary	The number of injections		Up to 6 months
Secondary	Number of injections		Up to 6 months
Secondary	Frequency of injections		Up to 6 months
Secondary	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

External Links

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