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Vulvar Atrophy clinical trials

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NCT ID: NCT06333782 Not yet recruiting - Vulvar Atrophy Clinical Trials

Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation

Start date: March 31, 2024
Phase: N/A
Study type: Interventional

The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women with labia majora hypotrophy/atrophy. The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function & pain during injection). Participants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group. An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection

NCT ID: NCT05890092 Recruiting - Vulvar Diseases Clinical Trials

Vulvar Disease in Nigeria Observational Study

VdiN
Start date: May 3, 2023
Phase:
Study type: Observational [Patient Registry]

Vulvar disease in Nigeria A look at awareness within patients and health practitioners, self-reported and actual prevalence within communities in Nigeria

NCT ID: NCT05378269 Completed - Vulvar Atrophy Clinical Trials

Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA

DARE-VVA1
Start date: November 22, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to study the safety, PK and PD of Intravaginal Tamoxifen on postmenopausal women with vulvar vaginal atrophy.

NCT ID: NCT04705883 Completed - Breast Cancer Clinical Trials

Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

VIBRA
Start date: September 1, 2020
Phase: Phase 4
Study type: Interventional

VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)

NCT ID: NCT04147689 Completed - Vulvar Atrophy Clinical Trials

Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration

ESOLANE
Start date: November 18, 2019
Phase: N/A
Study type: Interventional

DESIRIAL® PLUS is a CE-marketed hyaluronic acid (since 2011) whose registered indications are moderate hypotrophy, severe hypotrophy or atrophy of the vulvar Labia Majora by subcutaneous injections. The aim is to restore volume, rehydrate and add tone and tension to connective tissue areas by filling. In this study, 71 female subjects above or equal to 18 years old at inclusion, who have moderate hypotrophy or severe hypotrophy or atrophy of the vulvar Labia Majora (according to investigator's judgement), who have given her informed consent and meet all the eligibility criteria, will be enrolled. Subjects will come to a total of 6 visits over a period of 12 months. An optional screening visit may be done before injection (additional visit). Proportion of patients having an improved perception of aesthetics (GAIS score after mirror self-examination) after baseline injection will be assessed. Global Aesthetic Improvement, Sexual function, subject's satisfaction, subject's symptoms, pain at injection and safety will be also assessed.

NCT ID: NCT04042766 Recruiting - Vulvar Atrophy Clinical Trials

Laser Vaginal Treatment for GSM

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned.

NCT ID: NCT02966925 Completed - Vulvar Atrophy Clinical Trials

Autologous Platelet Concentrate Combined to Hyaluronic Acid Obtained With Cellular Matrix® BCT-HA Kit and Vulvovaginal Dryness

Start date: March 2016
Phase: N/A
Study type: Interventional

Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms of vaginal atrophy include dryness, itching, burning and dyspareunia. This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who cannot benefit from reference treatments (hormonal therapies).To achieve this, 20 patients suffering from vulvovaginal dryness will be treated with one session of injections in the vulva, the posterior vaginal wall and the perineum, and followed-up for 6 months. Improvement of vaginal dryness will be primarily appreciated through Friedmann score and pH value, and secondarily through the Female Sexual Function Index (FSFI), as measured at baseline and 1, 3 and 6 months after the treatment.

NCT ID: NCT02937805 Completed - Vaginal Atrophy Clinical Trials

Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

Start date: October 2016
Phase: N/A
Study type: Interventional

Vulvovaginal atrophy is a common problem associated with decreased levels of estrogen. Typical symptoms include feelings of dryness and uncomfort of the mucous membranes of intimate area. The objective of this study is to investigate the effects of a non-hormonal moisturizing cream on symptoms and signs of vulvovaginal atrophy and dryness.

NCT ID: NCT01753102 Terminated - Vaginal Atrophy Clinical Trials

Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

Start date: November 6, 2012
Phase: Phase 3
Study type: Interventional

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 therefore classified as a human estrogen. The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is approved and marketed in the US.

NCT ID: NCT00453089 Not yet recruiting - Vaginal Atrophy Clinical Trials

VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women

Start date: June 2012
Phase: Phase 1/Phase 2
Study type: Interventional

To conduct a prospective, randomized, blinded, placebo controlled, dose escalation clinical trial in 4 cohorts of 10 postmenopausal women (total N=40) aged 45 to 65 years with at least one menopausal vaginal symptom, vaginal pH > 5.0 and > 20% parabasal vaginal epithelial cells.