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Completed

NCT Number: NCT03901131

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.

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.

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Key information

Conditions

Contraceptive

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Many locations

Multiple Locations, Peru

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Follow clinical administration

Primary outcomes

  1. Frequency of Adverse Events and Serious Adverse Events

    Time frame: Up to 6 months

Secondary outcomes

  1. The number of injections

    Time frame: Up to 6 months

  2. Number of injections

    Time frame: Up to 6 months

  3. Frequency of injections

    Time frame: Up to 6 months

  4. Comorbidities associated to greater incidence of AE and SAE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: PROMES

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 3, 2019
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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