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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY98-7040 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040) | Drug | Follow clinical administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events and Serious Adverse Events | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The number of injections | Up to 6 months | |
| Number of injections | Up to 6 months | |
| Frequency of injections |
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Inclusion Criteria:
Exclusion Criteria:
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Women who have been prescribed Mesigyna in Peru.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | Peru |
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.
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| 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. | Up to 6 months |
| ID | Term |
|---|---|
| C024319 | norethindrone enanthate |
| D004958 | Estradiol |
| C418365 | estradiol, norethindrone drug combination |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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