drugset / Trial / NCT03154125
Sayana® Press Extension Study
RandomizedParallel-groupSingle-blindOther
Summary
This is a randomized clinical trial designed to evaluate the effectiveness, safety and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) for 3 treatment cycles (12 months) of use.
Timeline
- Start
- 2017-09-22
- Primary completion
- 2020-05-30
- Completion
- 2020-11-18
Publications
- Burke HM, Packer C, Fuchs R, Brache V, Bahamondes L, Salinas A, Veiga N, Miller A, Deese J. Acceptability of the contraceptive Sayana(R) Press when injected every four months: Results from a twelve-month trial in Brazil, Chile and the Dominican Republic. Contraception. 2022 Sep;113:95-100. doi: 10.1016/j.contraception.2022.04.007. Epub 2022 Apr 26.
- Deese J, Brache V, Bahamondes L, Salinas A, Jorge A, Veiga N Jr, Fuchs R, Miller A, Taylor D, Halpern V, Dorflinger L. Contraceptive effectiveness, pharmacokinetics, and safety of Sayana(R) Press when injected every four months: a multicenter phase 3 trial. EClinicalMedicine. 2022 Jan 29;44:101273. doi: 10.1016/j.eclinm.2022.101273. eCollection 2022 Feb.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | medroxyprogesterone acetate | Other / unclassified | 104 mg | Subcutaneous |
Indications
No indication recorded.