check_circleStudy Completed

Contraceptive

Bayer Identifier:

19243

ClinicalTrials.gov Identifier:

NCT03901131

EudraCT Number:

Not Available

EU CT Number:

Not Available
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.

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - 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
  • - Women participating in an investigational program with interventions outside of routine clinical practice
    - Hypersensitivity to norethisterone enantate or estradiol valerate

Trial summary

Enrollment Goal
296
Trial Dates
August 2019 - February 2022
Phase
N/A
Could I Receive a placebo
No
Products
Mesigyna (Norethisterone enantate/estradiol valerate, BAY98-7040)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Peru

Primary Outcome

  • Frequency of Adverse Events and Serious Adverse Events
    date_rangeTime Frame:
    Up to 6 months

Secondary Outcome

  • The number of injections
    date_rangeTime Frame:
    Up to 6 months
  • Number of injections
    date_rangeTime Frame:
    Up to 6 months
  • Frequency of injections
    date_rangeTime Frame:
    Up to 6 months
  • 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.
    date_rangeTime Frame:
    Up to 6 months

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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