Clinical trials: Atrophic Vaginitis
Menopause, Postmenopausal Vaginal Atrophy
Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The aim of this trial is to compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, in postmenopausal women…
- Trial name
- NCT01085877
- Testing
- estradiol, 25 mcg
- Where
- Germany
- Volunteers
- 70 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
Atrophic Vaginitis
Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of AV and DIV
In this open label study, 50 eligible women will be assigned to receive the investigational product (IZN-6NVS) - 2.5 g of cream/day for 14 days, followed by 3 applications per week for the next 4 weeks.
- Trial name
- NCT02313545
- Testing
- IZN-6NVS Cream
- Where
- 3 sites in United States, Israel
- Volunteers
- 50 people
- Sponsor
- Izun Pharma Ltd
Atrophic Vaginitis, Vaginal Diseases
Evaluation of Gynecological Acceptability of a Health Care Product
The research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days.
- Trial name
- NCT04247022
- Testing
- Health care product (intimate gel)
- Where
- Brazil
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Herbarium Laboratorio Botanico Ltda
Menopausal and Perimenopausal Disorder, Unspecified, Atrophic Vaginitis
Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness
This is a pilot study, assessing the ability and safety of the use of VR101 intravaginal ring to relieve the symptoms of vaginal dryness, in peri and post-menopausal women. VR1010 is designed to release glycerol.
- Trial name
- NCT02029053
- Testing
- Vaginal Lubrication Ring for Vaginal Dryness
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- J3 Bioscience, Inc.
Atrophic Vaginitis
Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
The objectives of this study were to evaluate the therapeutic equivalence of the Test formulation, generic Estradiol Vaginal Cream United States Pharmacopoeia (USP), 0.01% (Teva Pharmaceuticals, United States of America) to the…
- Trial name
- NCT03294538
- Testing
- Generic Estradiol Vaginal Cream USP, 0.01%, Estrace® Vaginal Cream USP, 0.01%, Vehicle Vaginal Cream
- Where
- 44 sites in United States
- Volunteers
- 663 people
- Sponsor
- Actavis Inc.
Vaginal Atrophy in Breast Cancer Patients
Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced…
- Trial name
- NCT03740945
- Testing
- Prasterone (DHEA)
- Sponsor
- EndoCeutics Inc.
Atrophic Vaginitis
An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis
The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients
- Trial name
- NCT05432154
- Testing
- Film forming silicone gel (7-0940)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Stratpharma AG
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
Vaginal Atrophy
Topical DHEA Against Vaginal Atrophy
The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.
- Trial name
- NCT01846442
- Testing
- DHEA (0.25%), DHEA (0.5%), DHEA (1.0%)
- Where
- 8 sites in United States, Canada
- Volunteers
- 218 people
- Sponsor
- EndoCeutics Inc.
Atrophic Vaginitis Due to Menopause
Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo
The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the efficacy of each of the 2 active treatments…
- Trial name
- NCT01779947
- Testing
- Estradiol Vaginal Tablets 10 mcg
- Where
- 25 sites in United States
- Volunteers
- 519 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Menopause, Postmenopausal Vaginal Atrophy
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.
- Trial name
- NCT00431132
- Testing
- estradiol, 10 mcg
- Where
- 42 sites in Czechia, Denmark and 5 more
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Menopause, Postmenopausal Vaginal Atrophy
Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.
- Trial name
- NCT00465192
- Testing
- estradiol, 10 mcg, estradiol, 25 mcg
- Volunteers
- 230 people
- Sponsor
- Novo Nordisk A/S
Atrophic Vaginitis
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo.
- Trial name
- NCT02195986
- Testing
- Estradiol Vaginal Cream, 0.01%, Estrace® 0.01% cream
- Where
- 21 sites in United States
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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
Atrophic Vaginitis, Atrophy
Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis
This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.
- Conditions
- Atrophic Vaginitis, Atrophy, Vaginitis
- Trial name
- NCT00137371
- Testing
- PVC (daily for 21 days, 7 days off), PVC (twice weekly)
- Where
- 49 sites in United States, Canada
- Volunteers
- 480 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Menopause, Postmenopausal Vaginal Atrophy
Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency
This study is conducted in Europe. The aim of this study is to investigate the self-reported impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic vaginitis due to oestrogen deficiency.
- Trial name
- NCT01507454
- Testing
- estradiol, 25 mcg
- Where
- Germany
- Volunteers
- 1,613 people
- Sponsor
- Novo Nordisk A/S
Atrophic Vaginitis, Atrophic Vulvovaginitis
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
This clinical study will evaluate the efficacy and safety of F-GYN, a sterile injectable medical device containing non-crosslinked hyaluronic acid, in adult women with moderate to severe vaginal dryness and symptoms related to…
- Conditions
- Atrophic Vaginitis, Atrophic Vulvovaginitis, Vaginal Atrophy, Dyspareunia
- Trial name
- F-GYN (NCT07701863)
- Testing
- F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel, Standard Non-Hormonal Symptomatic Care
- Where
- 3 sites in Poland
- Volunteers
- 130 people
- Sponsor
- Biovico Sp. z o.o.
Vaginal Atrophy
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
- Trial name
- NCT01358760
- Testing
- DHEA
- Where
- 42 sites in United States, Canada
- Volunteers
- 450 people
- Sponsor
- EndoCeutics Inc.