Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
NCT00160173 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 221
Last updated 2022-09-13
Summary
This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
Conditions
- Postmenopausal Symptoms
Interventions
- DRUG
-
Estrogel
- OTHER
-
Placebo
Sponsors & Collaborators
-
Solvay Pharmaceuticals
collaborator INDUSTRY -
ASCEND Therapeutics
lead INDUSTRY
Principal Investigators
-
Global Clinical Director Solvay · Solvay Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-12-02
- Primary Completion
- 2005-09-06
- Completion
- 2005-09-06
Countries
- United States
Study Locations
More Related Trials
-
Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo
NCT01779947 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
NCT02995694 ·Status: COMPLETED ·Phase: PHASE3
-
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women
NCT00141544 ·Status: TERMINATED ·Phase: PHASE2
-
Effect of Estradiol Topical Products
NCT05645393 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Effects of Vaginal Estrogen on Serum Estradiol During Aromatase Inhibitor Therapy in Breast Cancer Patients with Vulvovaginal Atrophy: a Prospective Trial
NCT06654570 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Investigate the Pharmacokinetics & Safety Following One Application of 3 Different Doses 0.5,0.75,& 1.25 gm,a Transdermal Estradiol Cream (VML-0203), in Comparison to a Single Dose of EstroGel 1.25 gm to Healthy Post-menopausal Women.
NCT03556800 ·Status: UNKNOWN ·Phase: PHASE1
-
Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women
NCT02224313 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes
NCT00160342 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
NCT00465192 ·Status: COMPLETED ·Phase: PHASE3
-
Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
NCT00251082 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms
NCT01942668 ·Status: COMPLETED ·Phase: PHASE3
-
Estrogen Hormone Products
NCT05645406 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)
NCT04209543 ·Status: COMPLETED ·Phase: PHASE3
-
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
NCT02195986 ·Status: COMPLETED ·Phase: PHASE3
-
TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy
NCT02449902 ·Status: COMPLETED ·Phase: PHASE2
-
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women
NCT00141557 ·Status: TERMINATED ·Phase: PHASE2
-
Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy
NCT02967510 ·Status: COMPLETED ·Phase: PHASE2
-
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
NCT00446199 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
NCT03332303 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy
NCT02691936 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of Estradiol and Progesterone Microspheres for the Treatment of Climacteric Symptoms.
NCT00775242 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy
NCT02670785 ·Status: COMPLETED ·Phase: PHASE2
-
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II)
NCT04090957 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women
NCT00141570 ·Status: COMPLETED ·Phase: PHASE2
-
Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy
NCT05617820 ·Status: COMPLETED ·Phase: PHASE3