ContraceptivePROMESNCT03901131
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.
An observational study of Contraceptive, run by Bayer at 1 site in Peru.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Contraceptive
- What is being tested?
- Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)
- How many people
- 296 participants
- Where
- 1 sitePeru
- Study dates
- 26 Aug 2019to 17 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who have been prescribed Mesigyna in Peru.
Who may be able to join
- 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
Who cannot join
- Women participating in an investigational program with interventions outside of routine clinical practice
- Hypersensitivity to norethisterone enantate or estradiol valerate
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Contraceptive
- Being tested
- Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)Drug
Follow clinical administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events and Serious Adverse Events
Measured: Up to 6 months
Secondary outcomes (4)
The number of injections
Measured: Up to 6 months
Number of injections
Measured: Up to 6 months
Frequency of injections
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start26 Aug 2019
- Primary completion31 Aug 2021
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptiveStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901131
- Sponsor's protocol ID
- 19243
- Acronym
- PROMES
- Status last verified
- Dec 2022
- First submitted
- 20 Feb 2019
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03901131
- Acronym / sponsor ID
- PROMES / 19243
- Conditions
- Contraceptive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY98-7040 | – | Drug: Norethisterone enantate/estradiol valerate (Mesigyna, 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who have been prescribed Mesigyna in Peru.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Women participating in an investigational program with interventions outside of routine clinical practice
- Hypersensitivity to norethisterone enantate or estradiol valerate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)Follow clinical administration | Drug | BAY98-7040 |
Primary outcome
Frequency of Adverse Events and Serious Adverse Events
Time frame: Up to 6 months
4 secondary outcomes
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
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraceptive, run by Bayer at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events and Serious Adverse Events (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.