Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures

Phase 3 Completed 352 enrolled Ferring Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to assess the safety of Progesterone Vaginal Ring (PVR) in women undergoing fresh embryo transfer (ART).

Timeline

Start: 2018-07-26
Primary completion: 2019-07-29
Completion: 2019-07-29

Outcome

Met primary endpoint

paper The spontaneous abortion rate was 7.4%, with the upper bound of the 95% confidence interval (11.5%) below the predefined threshold of 15.0%. PMID 42213348 ↗

Publications

Stadtmauer LA, Schnell VL, Park JK, Slater CC, Foster ED, Grover SA, Heiser PW. Safety evaluation of a novel progesterone vaginal ring (PVR) for luteal phase support: SARA trial. Drug Deliv Transl Res. 2026 May 29. doi: 10.1007/s13346-026-02158-x. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Progesterone	Other / unclassified	—	Other

Indications

No indication recorded.