Post Marketing Surveillance Study For Sayana®

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

POST MARKETING SURVEILLANCE TO OBSERVE SAFETY AND EFFICACY OF SAYANA(REGISTERED) USED FOR CONTRACEPTION AND MANAGEMENT OF ENDOMETRIOSIS-ASSOCIATED PAIN

ClinicalTrials.gov ID

NCT02104557

Acronym / sponsor ID

SAYANA / A6791036

Conditions

Product Surveillance, Postmarketing

Keywords

Sayana, Pregnancy, Contraception, Endometriosis-associated pain, PMS, Post Marketing Surveillance

Study type

Observational

Recruitment status

Completed

Enrolment

362 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

13 Feb 2014 (actual)

Primary completion

5 Jun 2020 (actual)

Study completion

5 Jun 2020 (actual)

First posted

4 Apr 2014 (estimated)

Results

Posted 10 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Other

Time perspective

Prospective

Number of arms

2

Who may qualify

Ages

0 years and older

Sex

Female only

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Study population

Women subjects who are initiating treatment with Sayana® for the first time as per the local product document for usage

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

   Time frame: Baseline up to a maximum of 12 months

   An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both serious and all non-serious adverse events.

2. Number of Participants Discontinued From Study Due to AEs

   Time frame: Baseline up to a maximum of 12 months

   Participants who discontinued permanently from the study due to AEs are reported. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.

3. Number of Participants Used Concomitant Medications for Treating AEs

   Time frame: Baseline up to a maximum of 12 months

   Number of participants taking any medications other than Sayana (concomitant medication) to treat AEs are reported.

4. Number of Participants With Clinically Significant Laboratory Test Abnormalities

   Time frame: Baseline up to a maximum of 12 months

   Laboratory tests included hematology, biochemistry, and urinalysis. Clinical significance was identified by investigators' judgements based on laboratory test results.

5. Percentage of Participants Who Became Pregnant Over Observation Period

   Time frame: Baseline up to 12 months

   The cumulative percent of participants who became pregnant over observation period was calculated as 100*(1- Kaplan-Meier curve at month 12), where the Kaplan-Meier (KM) method for estimating survival function was applied to time-to-pregnancy.

6. Rate of Pregnancies Per 100 Participant-years of Follow-up

   Time frame: Baseline up to 12 months

   Pregnancies per 100 person-years of follow-up defined as major events, incidence rate was calculated as: 100*(total number of participants with effectiveness endpoint)/(total person-years of participants included in the effectiveness analysis set) where total person-years is equal to (last evaluation date of outcome - first date of administration +1)/365.25 for all participants in the effective analysis set.

7. Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of First Dose (Month 3) of Study Drug

   Time frame: Baseline, Month 3

   Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 millimeter (mm) horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of first dose of study drug is reported in this outcome measure.

8. Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Second Dose (Month 6) of Study Drug

   Time frame: Baseline, Month 6

   Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of second dose of study drug is reported in this outcome measure.

9. Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Third Dose (Month 9) of Study Drug

   Time frame: Baseline, Month 9

   Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of third dose of study drug is reported in this outcome measure.

10. Change From Baseline in in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Fourth Dose (Month 12) of Study Drug

    Time frame: Baseline, Month 12

    Participants were asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of fourth dose of study drug is reported in this outcome measure.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.
• Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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.

19 sites in 1 country: see every site and its status.