drugset / Trial / NCT00108849
Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.
Timeline
- Start
- 2005-03
- Primary completion
- 2007-05
- Completion
- 2007-05
Publications
- Results Mettler L, Olsen PG. Long-term treatment of atrophic vaginitis with low-dose oestradiol vaginal tablets. Maturitas. 1991 Dec;14(1):23-31. doi: 10.1016/0378-5122(91)90144-f.
- Derzko CM, Rohrich S, Panay N. Does age at the start of treatment for vaginal atrophy predict response to vaginal estrogen therapy? Post hoc analysis of data from a randomized clinical trial involving 205 women treated with 10 mug estradiol vaginal tablets. Menopause. 2020 Oct 5;28(2):113-118. doi: 10.1097/GME.0000000000001666.
- Simon J, Nachtigall L, Ulrich LG, Eugster-Hausmann M, Gut R. Endometrial safety of ultra-low-dose estradiol vaginal tablets. Obstet Gynecol. 2010 Oct;116(4):876-883. doi: 10.1097/AOG.0b013e3181f386bb.
- Simon J, Nachtigall L, Gut R, Lang E, Archer DF, Utian W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstet Gynecol. 2008 Nov;112(5):1053-60. doi: 10.1097/AOG.0b013e31818aa7c3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 10 ug | Other |