Trial Condition(s):
Contraceptive
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)
Bayer Identifier:
19243
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many locations Many locations, Peru | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
1
Primary Outcome
- Frequency of Adverse Events and Serious Adverse EventsTimeframe: Up to 6 months
Secondary Outcome
- The number of injectionsTimeframe: Up to 6 months
- Number of injectionsTimeframe: Up to 6 months
- Frequency of injectionsTimeframe: Up to 6 months
- Comorbidities associated to greater incidence of AE and SAEThe associated factors for AE for contraceptives are headaches, acne, obesity, hypertension, breast tenderness, dysmenorrhea, nausea. This could get worse with the use of contraceptives.Timeframe: Up to 6 months
Additional Information
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