drugset / Trial / NCT04393194
The Effect of Intra-vaginal Conjugated Estrogen Cream on Ring Pessary Use for Pelvic Organ Prolapse
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary purpose of this two-arm randomized clinical trial is to determine if in women desiring use of a pessary for pelvic organ prolapse (POP) and are successfully fit, if 1-year use and patient impression of improvement is superior in women using vaginal estrogen cream versus those using a vaginal placebo cream.
Timeline
- Start
- 2020-05-24
- Primary completion
- 2022-06-01
- Completion
- 2022-09-01
Outcome
Missed primary endpoint
paper Pessary continuation rate with satisfaction did not differ significantly between the oestrogen group and the placebo group PMID 40578851 ↗
Publications
- Zhou Y, Yin R, Zhang Y, Wang X, Jin F, Li X, Peng C, Wang P, Shen H, Weng Q, Xie H, Wang H, Jiang B, Zhou K, Liang N, He Y, Dai Y, Fang Z, Liang S, Zhang Y, Morse A, Zhu L. Effects of intravaginal conjugated oestrogen on pessary continuation for pelvic organ prolapse: multicentre, randomised, double blind, placebo controlled trial. BMJ. 2025 Jun 27;389:e084418. doi: 10.1136/bmj-2025-084418.
- Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | conjugated oestrogen | Unknown | 1 g | Other |