Clinical trials: Vaginal Atrophy
Menopause
A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal…
- Trial name
- NCT00196378
- Testing
- Synthetic Conjugated estrogens, B
- Where
- 38 sites in United States
- Volunteers
- 300 people
- Sponsor
- Duramed Research
Postmenopausal Osteoporosis, Postmenopause
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and medroxyprogesterone, Prempro™.
- Trial name
- NCT00381251
- Testing
- Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Vulvovaginal Atrophy
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.
- Trial name
- NCT01455597
- Testing
- WC3011 Estradiol Vaginal Cream
- Where
- 64 sites in United States
- Volunteers
- 309 people
- Sponsor
- Warner Chilcott
Atrophic Vaginitis, Vaginal Disease
Evaluation of Gynecological Acceptability of 3 Health Care Products
The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days.
- Trial name
- NCT04327947
- Testing
- Hyaluronic acid - Research product 1, Hyaluronic acid - Research product 2, Hyaluronic acid - Comparator product
- Where
- Brazil
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Herbarium Laboratorio Botanico Ltda
Menopause, Postmenopausal Vaginal Atrophy
Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis.
- Trial name
- NCT01486979
- Testing
- estradiol, 10 mcg, estradiol, 25 mcg
- Where
- Germany
- Volunteers
- 58 people
- Sponsor
- Novo Nordisk A/S
Atrophic Vaginitis
Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis
The purpose of this study is to characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in postmenopausal women with atrophic vaginitis.
- Trial name
- NCT00167921
- Testing
- Premarin® Vaginal Cream, Premarin® oral tablets
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Vaginal Atrophy
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
A Phase 2, Dose-ranging, 12-week Randomized, Double-blind, Placebo controlled, Parallel-group Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005% Estriol Vaginal Gel…
- Trial name
- NCT02967510
- Testing
- Estriol
- Where
- 23 sites in Czechia, Hungary and 3 more
- Volunteers
- 283 people
- Sponsor
- ITF Research Pharma, S.L.U.
Vulvar Atrophy, Vaginal Atrophy
Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol. The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is…
- Trial name
- NCT01753102
- Testing
- Estradiol
- Where
- India
- Volunteers
- 49 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Vulvar Atrophy
Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA
The purpose of the study is to study the safety, PK and PD of Intravaginal Tamoxifen on postmenopausal women with vulvar vaginal atrophy.
- Trial name
- DARE-VVA1 (NCT05378269)
- Testing
- Tamoxifen
- Where
- 2 sites in Australia
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
Dyspareunia
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
Randomized, double-blind, placebo-controlled, parallel-designed, multiple-site, bioequivalence study with clinical endpoints.
- Trial name
- NCT05617820
- Testing
- Estradiol, Imvexxy
- Where
- 48 sites in United States, El Salvador and 1 more
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Vulvovaginal Atrophy, Menopause
Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of vaginal looseness and for the treatment of the mons pubis and labia for skin tightening.
- Conditions
- Vulvovaginal Atrophy, Menopause, Menopause Surgical
- Trial name
- NCT03536585
- Testing
- Vulvovaginal treatment, Baseline
- Where
- 3 sites in Canada
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Vaginal Atrophy, Atrophic Vaginitis
ASSIST-VLA: Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy
Vaginal atrophy patients receiving vaginal laser therapy will be treated with daily 7-0940® following a laser session to evaluate the safety and efficacy of the product as an adjunct treatment.
- Conditions
- Vaginal Atrophy, Atrophic Vaginitis, Genitourinary Syndrome of Menopause (GSM)
- Trial name
- ASSIST-VLA (NCT07346287)
- Testing
- 7-940
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Stratpharma AG
Vaginal Atrophy
Exploratory Study on Two Different Doses of VML-0001 on the Effects on Vaginal pH in Healthy Post-Menopausal Women
The study is designed to determine the effect on vaginal pH and the duration of action measured on the ability of the base formulation to reduce the vaginal pH
- Trial name
- NCT03770065
- Testing
- VML-0001
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Viramal Limited
Atrophic Vaginitis
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
The purpose of this study is to assess the long term safety and efficacy of the vaginal application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on atrophic vaginitis in postmenopausal breast cancer…
- Trial name
- Gynoflor (NCT01370551)
- Testing
- Estriol 0.03 mg, lyophylized lactobacillus
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 16 people
- Sponsor
- Medinova AG
Vaginal Atrophy
Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.
Primary: Evaluation of improved vaginal moisture in postmenopausal women. Secondary: the improvement of symptoms resulting from the dryness Rating (VHI), evaluation of the decrease in vaginal pH, assessment of Sexual Function…
- Trial name
- NCT02571127
- Testing
- Hidra1
- Volunteers
- 46 people
- Sponsor
- Farmoquimica S.A.
Vulvovaginal Atrophy, Menopause
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.
- Conditions
- Vulvovaginal Atrophy, Menopause, Dyspareunia, Painful Intercourse
- Trial name
- REJOICE (NCT02253173)
- Testing
- Estradiol
- Where
- 105 sites in United States, Canada
- Volunteers
- 764 people
- Sponsor
- TherapeuticsMD
Vulvar and Vaginal Atrophy
Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
The objectives of this study are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients…
- Trial name
- NCT03332303
- Testing
- Estrace® Cream, Estradiol Vaginal Cream, Vehicle Cream
- Where
- 27 sites in United States
- Volunteers
- 540 people
- Sponsor
- Prasco LLC
Atrophy, Vaginal Diseases
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus
The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.
- Trial name
- NCT01586364
- Testing
- Ospemifene 60Mg Oral Tablet
- Volunteers
- 301 people
- Sponsor
- Shionogi
Menopause, Postmenopausal Vaginal Atrophy
Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms
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.
- Trial name
- NCT00108849
- Testing
- estradiol, 10 mcg
- Where
- 57 sites in United States, Canada
- Volunteers
- 309 people
- Sponsor
- Novo Nordisk A/S
Vagina Atrophy
Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity
Up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study.
- Trial name
- NCT04511260
- Testing
- NuEra Tight VRF Handpiece
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Lumenis Be Ltd.