Clinical Trials for Vulvar Disorders

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Vulvar Disorders from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 28
• Active, not recruiting: 9
• Completed: 6
• Other: 7

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT04169763 — Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery

This phase I trial studies the side effects and best dose of nelfinavir when given together with cisplatin and external beam radiation therapy in treating patients with vulvar cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery. Nelfinavir is an antiviral drug normally used to treat human immunodeficiency virus (HIV). Drugs used in chemothe…

NCT04717349 — Data Collection Study of Pediatric and Adolescent Gynecology Conditions

Background:

Gynecologic conditions are those that are related to the reproductive system. They can be reproductive gland disorders or reproductive system tumors. They can also be inborn anomalies of the reproductive tract. Researchers want to gather data over time from a large group of young people with these conditions.

Objective:

To create a database about child and teenage gynecologic con…

NCT05000294 — Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies.

Despite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically “…

NCT05686226 — E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers

This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.

NCT05969860 — At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer

This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from f…

NCT05743517 — Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)

The primary purpose of the study is to determine which of four components (symptom-burden tailored app, exercise partner, oncology provider engagement, coaching) added to a core intervention of a wearable activity tracker and commercially available app, will improve physical activity. The findings will generate meaningful knowledge about how to best increase physical activity in older gynecolog…

NCT06039111 — Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma

The aim of this study is to confirm prospectively if the use of near infrared-indocyanine green (NIR-ICG) alone offers similar accuracy and sensitivity to the gold standard dual technique for sentinel lymph node detection in early stage vulvar cancer.

NCT05979610 — Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies

The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies.

Participants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Que…

NCT06023862 — A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)

Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma.

198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio.

1. Group A: Dostarlimab monotherapy

   • First 3 cycles: Dostalimab 500mg every 3 weeks, IV
   • 4 cycles ~ up to 2…

NCT06339827 — ASk Questions in GYnecologic Oncology (ASQ-GYO)

The goal of this clinical trial is to determine the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL) at improving patient self-efficacy, distress, physician trust, and knowledge compared to usual care during new patient gynecologic oncology visits. Also to determine the acceptability of the ASQ-GYO QPL with new gynecologic oncology patients.

NCT06638931 — Agnostic Therapy in Rare Solid Tumors

The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.

The study aims to treat rare malignancies with PD-L1 expression (CPS ≥ 10), regardless of the tumor’s tissue type or location. Patients who have not responded to standard treatments will be included, …

NCT06495554 — Danish Vulva Cancer Recurrence Study

The overall aim is to investigate different aspects of recurrence detection in women with vulva cancer (VC) to identify optimal treatment- and surveillance programs.

DaVulvaRec is a Danish nationwide multicenter study with patient inclusion from Aarhus University Hospital and Rigshospitalet, Denmark. Applying a mixed method research design, the investigators will collect and analyze patient-re…

NCT06660212 — Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health

This trial will provide evidence for the effective management of pain and pain-related domains among those who experience provoked vestibulodynia (PVD) using photobiomodulation (PBM) and multimodal physiotherapy (mPT) in a randomized controlled trial (RCT). PVD is the most common subcategory of vulvovaginal pain experienced during sexual and non-sexual activities, affects the psychological and …

NCT06975410 — Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors

This is a study for people with locally advanced or metastatic cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with Epidermal Growth Factor Receptor (EGFR) overexpressing can join the study. The purpose of this study is to find out whether a medicine called YH32364 helps people with locally advanced or metastatic cancers with EGFR overexpression.

NCT05903833 — Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy

Evaluation of efficacy and safety of pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulva cancer.

NCT07109869 — Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis

This is a Phase 3 clinical study to evaluate the efficacy, safety, and tolerability of boric acid 600 mg vaginal inserts in patients with VVC.

NCT05639972 — E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

The goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival.

This study see…

NCT07124000 — DESTINY-PANTUMOUR04

This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US

NCT07217171 — A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas

The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in t…

NCT07407647 — Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer

This phase II trial tests the feasibility and side effects of vaginal DHEA to improve vaginal health after radiation for women with gynecologic, anal or rectal cancer. Treatment of cancers with radiation to the abdomen can influence the vaginal microbiome (any bacteria, virus, or other organisms found in the vagina). Both menopause and radiation cause a decrease in lubrication and elasticity of…

NCT07454642 — AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors

This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the …

NCT07553715 — Effectiveness of a Four-Session Focal Shock Wave Therapy Protocol in Women With Vulvodynia

Vulvodynia is a chronic vulvar pain condition that can significantly affect quality of life. Low-intensity focal extracorporeal shock wave therapy has been proposed as a non-invasive therapeutic option, but real-world data remain limited.

This retrospective observational study aims to evaluate the effectiveness of a four-session focal shock wave therapy protocol in women with vulvodynia treate…

NCT05434104 — The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study

Three-quarters of women have bacterial vaginosis (BV) or vaginal thrush/candida yeast infection at least once during their lifetime. Symptoms can include abnormal vaginal discharge, soreness, itching and an unpleasant smell. BV during pregnancy can make the baby come too early. In the UK over a million women suffer recurrent vaginal infections. These can affect their sexual relationships and qu…

NCT07534345 — Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse

Chronic vulvar pain is a highly prevalent and debilitating condition affecting up to 16% of women. The most common subtype of vulvar pain, provoked vestibulodynia (PVD), is characterized by a sharp pain at the entry of the vagina in response to pressure or attempted vaginal penetration. Women with PVD not only present with psychological distress and significant disruption in all aspects of sexu…

NCT07603895 — Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis

Open-label, randomized clinical trial with a control group and a 4-week intervention period. The study will evaluate the efficacy of the probiotic supplement Bioithas WOMAN® as an adjunctive treatment in women with clinically suspected vulvovaginal candidiasis (VVC).

All participants will receive the antifungal treatment prescribed by the investigator. Participants allocated to the probiotic g…

NCT07521137 — Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of OCF001 Intravaginal Gel in Women with Acute Vulvovaginal Candidiasis

NCT07667192 — Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer

REGYNERA(dia)TION is an international, multicenter, ambispective observational patient registry of adults with recurrent gynecologic malignancies after prior radiotherapy who are treated or planned for reirradiation and/or total ablative strategies as part of routine clinical care. The registry does not assign treatment. Radiotherapy technique, dose, systemic therapy, surgery, metastasis-direct…

NCT07424664 — A Single-arm, Multicenter Clinical Study of Becotatug Vedotin Combined With Zimberelimab in the Treatment of Recurrent and Metastatic Cervical Cancer, Vulvar Cancer and Vaginal Cancer

This is a prospective, multicenter, single-arm clinical trial investigating Becotatug Vedotin in combination with Zimberelimab for the treatment of patients with recurrent and metastatic cervical cancer, vulvar cancer, and vaginal cancer. A total of 30 patients are expected to be enrolled. The study consists of a screening period (within 28 days), a treatment period, and a follow-up period (saf…

Active, Not Recruiting

NCT02834013 — Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

This trial enrolls participants for the following cohorts based on condition:

1. Epithelial tumors of na…

NCT02978625 — Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers

This phase II trial studies how well talimogene laherparepvec and nivolumab work in treating patients with lymphomas that do not responded to treatment (refractory) or non-melanoma skin cancers that have spread to other places in the body (advanced) or do not responded to treatment. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimul…

NCT04430699 — Cisplatin+Pembrolizumab+RT in Vulvar Cancer

This research is being done to see how well the combination of a standard of care drug, investigational drug, and radiation therapy work against unresectable vulvar squamous cell carcinoma.

This research study involves the following:

• Cisplatin (standard of care drug)
• Pembrolizumab (investigational drug)
• Radiation Therapy (standard of care intervention)

NCT04432597 — HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers

Background:

For some cancers associated with human papillomavirus (HPV), standard treatments are not helpful. Researchers want to see if a vaccine for HPV combined with a drug called M7824 (MSB0011359C) has a better effect on these cancers than when they work alone.

Objective:

To find a safe dose of HPV vaccine alone or combined with M7824. Also, to test if either HPV vaccine alone or combin…

NCT04713618 — Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy

This study investigates changes in physical measures of pelvic health and patient-reported outcomes of sexual function, intimate relationship, and quality of life over time in women undergoing radiation therapy for pelvic cancer. Evaluating vaginal changes prior to and after a course of radiation and collecting patient reported outcomes of sexual function, partner communication, and intimacy ma…

NCT04708470 — A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers

Background:

Often, metastatic human papillomavirus (HPV) associated cancers cannot be cured. They also do not respond well to treatment. Some forms of colon cancer also have poor responses to treatment. Researchers want to see if a new drug treatment can help people with these types of cancers.

Objective:

To find a safe dose of entinostat in combination with PDS01ADC and bintrafusp alfa and …

NCT04930107 — Vulvovaginal Candidiasis in Canadian Females

Vulvovaginal candidiasis (VVC; colloquially referred to as a ‘yeast infection’) is a prevalent mucosal infection caused by Candida spp. that affects ~75% of women at least once in their life. VVC usually responds well to treatment, yet a small but significant fraction of women experience recurrent yeast infections even with weekly treatment. A further complication in understanding the causes o…

NCT05934851 — A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia

The purpose of this study is to compare “Frozen-Section Directed Excision”, which has been a proven method of surgery used in dermatology, versus the current, standard method called “Wide Local Excision” to treat high-grade vulvar dysplasia.

NCT07405853 — An Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Vulvovaginal Candidiasis Compared With an Untreated Control Group

The goal of this clinical trial is to learn if pHyph works to reduce signs and symptoms of vulvovaginal candidiasis (thrush). It will also learn about the safety of pHyph. The main questions it aims to answer are:

• Does pHyph reduce the signs and symptoms of vulvovaginal candidiasis after an initial 6 day daily treatment?
• Does an additional 6 day treatment course after the initial one furth…

Not Yet Recruiting

NCT07607470 — Large Algorithm Setting and Validation Study

In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay.

The Nanopath assay is an amplification-free molecular test that detects pathogens …

NCT06233331 — Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV

The goal of this study is to test the maximum tolerated dose of ACU-D1 in HIV-positive people with HPV-associated vulvar and perianal lesions. The main questions it aims to answer are:

• The maximum tolerated dose of ACU-D1
• Safety and tolerability of topical ACU-D1
• Whether topical ACU-D1 induces p53 and p53-mediated downstream signaling (including p21 induction) in HPV-related lesions
• Wh…

NCT07672782 — Tisotumab Vedotin in Squamous Cell Carcinoma of the Vulva

This is an open-label, single arm, phase 2 study designed to evaluate the efficacy of tisotumab vedotin in participants with recurrent or metastatic squamous cell carcinoma of the vulva by estimating the objective response rate.

Patients will receive tisotumab vedotin every 3 weeks (21 days plus or minus 3 days). Treatment will continue until either unacceptable toxicity, progression of diseas…

Enrolling by Invitation

NCT07594327 — Quality of Life and Sexuality After Pelvic Exenteration for Gynecologic Cancer

Pelvic exenteration is an exceptionally extensive and very rare surgical procedure, most commonly used in the treatment of locally recurrent cervical cancer among gynecological malignancies. It is typically performed with curative intent when no other treatment options remain feasible.

The aim of this study is to examine the quality of life and sexuality of patients who have undergone pelvic e…

Completed Trials

NCT02379520 — HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA

Subjects have a type of cancer that has been associated with an infection with a virus called human papilloma virus (HPV). The cancer has come back, has not gone away after standard treatment or the subject cannot receive standard treatment.

This is a research study using special immune system cells called HPVST cells, a new experimental treatment.

Investigators want to find out if they can u…

NCT03180294 — Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer

This phase II randomized trial studies how well bupropion hydrochloride works in improving sexual desire in women with breast or gynecological cancer. Bupropion hydrochloride may work by boosting sexual desire, energy, or motivation without causing intolerable or undesirable side effects.

NCT04287868 — Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies

Background:

More than 30,000 cases of human papillomavirus (HPV) associated cancers occur annually in the United States. When these cancers spread, they do not respond well to standard treatments and are often incurable. Researchers want to see if a mix of drugs can help.

Objective:

To learn if a mix of immunotherapy drugs can shrink tumors in people with HPV associated cancers.

Eligibility…

NCT05597358 — Efficacy of High Intensity Laser for Provoked Vestibulodynia

This is a multicenter randomized controlled trial (RCT) investigating the effects of laser treatments in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses. Eligible participants will then be asked to complete a consent form and the bas…

NCT06474247 — Postbiotic as Adjunct Treatment for Vaginal Candidiasis

This project aims to study the efficacy of oral administration of postbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks compared to placebo.

NCT07232446 — Effect of Vulvar Re-Antisepsis Before CO₂ Cystoscopy Performed After Laparoscopic Hysterectomy on Postoperative Urinary Infections

This prospective observational study aims to evaluate whether additional vulvar re-antisepsis before intraoperative cystoscopy reduces the incidence of postoperative urinary tract infections (UTIs) in patients undergoing total laparoscopic hysterectomy for benign indications. In our institution, cystoscopy is routinely performed at the end of laparoscopic hysterectomy using carbon dioxide (CO₂)…

Other (Suspended)

NCT03987555 — Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

The goals of this prospective, observational cohort study are to determine the feasibility of implementing paclitaxel therapeutic drug monitoring for cancer patients and explore the relationship between paclitaxel drug exposure and the development of neuropathic symptoms.

This trial studies if paclitaxel can be consistently measured in the blood of patients with solid tumors undergoing paclita…

Other (Terminated)

NCT04519697 — Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn’s Disease

Approximately 10% of all female Crohn’s patients have a rectovaginal fistula. Rectovaginal fistulas cause air, stool, and/or drainage per vagina and may be associated with pain, recurrent urinary tract infections and diminished quality of life. Conventional therapy includes immunosuppressive medications used to treat Crohn’s disease and various surgical interventions. However, all have limited …

NCT05949632 — A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

This study is being conducted to evaluate the safety and tolerability of INCB099280 in combination with axitinib and to assess the antitumor activity of INCB099280 in combination with axitinib. This study will only be open in the UK and EU.