An observational study in Contraceptive, sponsored by Bayer. Completed at 1 site in Peru. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-12-21.
Sponsored by Bayer · Observational
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.
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women who have been prescribed Mesigyna in Peru.
Exclusion Criteria:
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)
Follow clinical administration
Frequency of Adverse Events and Serious Adverse Events
Time frame: Up to 6 months
The number of injections
Time frame: Up to 6 months
Number of injections
Time frame: Up to 6 months
Frequency of injections
Time 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.
Time frame: Up to 6 months
Plan to share: Undecided — Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bayer