Phase 4 study of Sayana Press in Adult Women
Research type
Research Study
Full title
Phase IV Open Label single group one year study of home self-injection with SAYANA® press in adult women of reproductive age - a pragmatic clinical trial
IRAS ID
216486
Contact name
Nancy Sherman
Contact email
Sponsor organisation
Pfizer Inc.,
Clinicaltrials.gov Identifier
NIHR commercial study identifier, REPR 32103
Duration of Study in the UK
1 years, 10 months, 26 days
Research summary
This is a 1-year study to assess home self-injection of the long-acting contraceptive Sayana Press in adult women.
Women who are judged by their health care provider to be good candidates for self-injection will be given training and a supervised first self-injection at the clinic.
They will then self-inject Sayana Press at home every 3 months (Month 3, Month 6 and Month 9) and return for a final study visit at Month 12 where they will complete a questionnaire regarding their experience with self-injection during the study.REC name
East of Scotland Research Ethics Service REC 1
REC reference
17/ES/0030
Date of REC Opinion
6 Apr 2017
REC opinion
Further Information Favourable Opinion