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.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03901131

Acronym

PROMES

Enrollment

296

Registered

2019-04-03

Start date

2019-08-26

Completion date

2022-02-17

Last updated

2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive

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.

Interventions

DRUGNorethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)

Follow clinical administration

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency of Adverse Events and Serious Adverse Events	Up to 6 months

Secondary

Measure	Time frame	Description
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	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.

Countries

Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026