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.

NCT03901131 | Completed

• 1 other identifier: 19243
• Study Type: observational
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraceptive

Outcome Measures

Primary Outcomes (1)

• Frequency of Adverse Events and Serious Adverse Events

  Up to 6 months

Secondary Outcomes (4)

• 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

  Up to 6 months

Study Arms (1)

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.

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

Interventions

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

Follow clinical administration

BAY98-7040

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who have been prescribed Mesigyna in Peru.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Peru

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Interventions

norethindrone enanthate; Estradiol; estradiol, norethindrone drug combination

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: April 3, 2019
• Study Start: August 26, 2019
• Primary Completion: August 31, 2021
• Study Completion: February 17, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

PE (1)