Clinical trials: Atrophy of Vagina
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
Genitourinary Syndrome of Menopause, Vulvovaginal Atrophy
Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy
The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of symptoms related to genitourinary syndrome of menopause (GSM)/vulvovaginal atrophy (VVA).
- Conditions
- Genitourinary Syndrome of Menopause, Vulvovaginal Atrophy, Menopause
- Trial name
- NCT04607798
- Testing
- Radiofrequency and pulsed electro-magnetic fields treatment
- Where
- Ukraine
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Atrophy Vulva
POST-MARKETING CLINICAL STUDY to EVALUATE the EFFICACY and SAFETY of the VAGINAL FILLER MEDICAL DEVICE in CORRECTING THINNING of the GENITAL TISSUE of the LABIA MAJORA in WOMEN, RE-PROPORTIONING the FEMALE EXTERNAL GENITAL AREA and IMPROVING SEXUAL FUNCTION.
The overall aim of this research is to gather more information on the effectiveness of the Vaginal Filler medical device used in women to correct the thinning of the external genital tissue of the labia majora, re-proportioning…
- Trial name
- NCT06797167
- Testing
- Injections of a filler gel containing cross-linked hyaluronic acid
- Where
- Italy
- Volunteers
- 76 people
- Sponsor
- Rose Pharma SA
Vulvovaginal Atrophy
Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
This study evaluates the efficacy and safety of hyaluronic acid derivative based vaginal pessaries for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.
- Trial name
- NCT03557398
- Testing
- Hydeal-D vaginal pessaries
- Where
- 2 sites in Slovakia
- Volunteers
- 40 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women
The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg…
- Trial name
- NCT00630539
- Testing
- Ospemifene 5 mg, Ospemifene 15 mg, Ospemifene 30 mg
- Volunteers
- 126 people
- Sponsor
- Shionogi
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.
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.
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
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
Vaginal Atrophy
Real-world Evidence Study on the Performance and Safety of Halova Ovules
An open-label, multicentric, non-randomized, single-arm, pilot, interventional clinical investigation to confirm the tolerability and performance of the medical device Halova in lubrication of the vagina and vaginal atrophy…
- Trial name
- NCT05654610
- Testing
- Halova
- Where
- 14 sites in Romania
- Volunteers
- 249 people
- Sponsor
- Perfect Care Distribution
Vulvovaginal Atrophy
Performance and Safety of Hyalo Gyn Gel on the Treatment of Vaginal Atrophy in Postmenopausal Women
This clinical investigation evaluates the performance and safety of Hyalo Gyn, a hyaluronic acid derivative based vaginal gel for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.
- Trial name
- NCT04355403
- Testing
- Hyalo Gyn gel in prefilled applicators
- Where
- 2 sites in Slovakia
- Volunteers
- 80 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Atrophic Vaginitis, Vaginal Atrophy
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term…
- Conditions
- Atrophic Vaginitis, Vaginal Atrophy, Genitourinary Syndrome of Menopause, Lichen Sclerosus of Vulva
- Trial name
- VALOR (NCT05953090)
- Testing
- 7-0940
- Where
- 14 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Stratpharma AG
Postmenopausal Symptoms
Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
- Trial name
- NCT00160173
- Testing
- Estrogel
- Where
- 109 sites in United States
- Volunteers
- 221 people
- Sponsor
- ASCEND Therapeutics
Vaginal Atrophy
Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the…
- Trial name
- NCT02013544
- Testing
- Prasterone (DHEA)
- Where
- 38 sites in United States, Canada
- Volunteers
- 558 people
- Sponsor
- EndoCeutics 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
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
- Trial name
- NCT01256684
- Testing
- DHEA
- Where
- 33 sites in United States, Canada
- Volunteers
- 255 people
- Sponsor
- EndoCeutics Inc.
Postmenopausal Vaginal Atrophy
Vaginal Estradiol Tablets (Vagifem®) and Endometrial Cancer Risk in the Treatment of Postmenopausal Vaginal Atrophy
The study will include data from a nationwide Danish cohort of postmenopausal women and the United States of America (US) cohort of postmenopausal women.
- Trial name
- NCT05243823
- Testing
- Vagifem®, Non-Vagifem® LDVE, Estradiol
- Where
- Denmark
- Volunteers
- 500,000 people
- Sponsor
- Novo Nordisk A/S
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
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
Twelve month extension of a previous study of Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia for improvement in skin laxity.
- Conditions
- Vulvovaginal Atrophy, Menopause, Menopause Surgical
- Trial name
- NCT04210583
- Testing
- Vulvovaginal Treatment
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Venus Concept
Atrophy, Vaginal Diseases
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
- Trial name
- NCT00729469
- Testing
- Ospemifene 60 mg
- Volunteers
- 919 people
- Sponsor
- Shionogi