WHO ICTRP trial
A clinical study to evaluate bioequivalence of Estradiol Vaginal Cream (0.01%…
CTRI/2016/09/007231 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2016/09/007231 |
|---|---|
| Public title | A clinical study to evaluate bioequivalence of Estradiol Vaginal Cream (0.01% from Cipla) and Estrace® Estradiol Vaginal Cream (0.01% from Warner Chilcott Inc.) with clinical endpoint in Postmenopausal Females with Vulvar and Vaginal atrophy. |
| Scientific title | A Randomized, Double Blind, Active and Placebo Controlled, Comparative, Multi-center Study to evaluate bioequivalence of Estradiol Vaginal Cream (0.01% from Cipla) and Estrace® Estradiol Vaginal Cream (0.01% from Warner Chilcott Inc.) with clinical endpoint in Postmenopausal Females with Vulvar and… |
| Primary sponsor | Cipla Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3/ Phase 4 |
| Countries | India |
| Conditions | Health Condition 1: null- Vulvar and Vaginal atrophy |
| Interventions | Intervention1: Estradiol vaginal cream (0.01%): Cipla Ltd. Dose: 2 gm Frequency: once daily Duration: 7 days Route of Administration: Vaginal Control Intervention1: Estrace® Estradiol Vaginal Cream (0.01%): Warner Chilcott Inc. Dose: 2 gm… |
| Registration date | Jan 9, 2016 |
| Target size | 345 |
| Secondary IDs | Protocol Number CRD/03 , Version NO. 01 dated 19 April 2016 |
| Registry page | ctri.nic.in |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: