Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196378
Status:
COMPLETED
Last Update Posted:
2013-09-02
First Post:
2005-09-13
Brief Title:
A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 03 mg for the Treatment of Vulvovaginal Atrophy
Sponsor:
Duramed Research
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Randomized Multicenter Double-blind Placebo-controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens B Enjuvia 03 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a two-arm randomized double-blind parallel-group placebo-controlled study to evaluate the efficacy of Enjuvia 03 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy andor oophorectomy
Detailed Description:
The study will include a screening period up to 4 weeks and a 12-week treatment period The overall study duration for participants will be approximately 16 weeks Study participants will undergo physical and gynecological exams and blood tests for clinical laboratory assessments All patients with a uterus will undergo transvaginal ultrasound
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None