4 completed, 4 terminated, 2 not yet recruiting, 2 recruiting. 14 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Completed 4, Terminated 4, Not yet recruiting 2, Recruiting 2, Active not recruiting 1, Withdrawn 1 |
| Phase 3 | 2 | Not yet recruiting 1, Terminated 1 |
Follow Vulvodynia: new trials by email Literature Review of Vulvodynia trials Research Report on Vulvodynia
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia Low Dose Naltrexone - Vulvodynia | Phase 2 | Not yet recruiting | University of Florida | 20 | 2027-01-01 | 2026-10-09 |
| Topical Ketotifen 0.25% for Secondary Vestibulodynia Ketotifen Fumarate 0.25% Cream, Placebo (Vehicle Cream) - Provoked Vestibulodynia, Secondary Provoked Vestibulodynia | Phase 2 | Recruiting | Center for Vulvovaginal Disorders | 54 | 2026-01-02 | 2026-03-18 |
| A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia) Pudafensine - Vulvodynia | Phase 2 | Active not recruiting | Initiator Pharma | 24 | 2025-12-17 | 2026-11-06 |
| Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial Estradiol 0.01% Vag Cream, testosterone 0.1% and estradiol 0.01% vaginal cream - Vulvodynia, Dyspareunia | Phase 2 / Phase 3 | Not yet recruiting | TriHealth Inc. | 44 | 2025-12-01 | 2025-12-03 |
| Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia Naltrexone Hydrochloride - Vulvodynia, Naltrexone | Phase 2 | Recruiting | Medical University of Lublin | 300 | 2023-05-31 | 2023-07-21 |
| Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments 5% lidocaine/5 mg/ml 0.02% estradiol compound cream, Nortriptyline, Placebo cream - Vestibulodynia, Temporomandibular Disorder | Phase 2 | Completed | Duke University | 209 | 2019-11-04 | 2026-03-19 |
| Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment 5% sinecatechins ointment, Placebo, 10% sinecatechins ointment - Sexual Pain Disorders, Postmenopausal Symptoms | Phase 2 | Terminated | GTO Pharmaceutical, LLC | 32 | 2018-08-30 | 2022-07-27 |
| Dysport in Vulvodynia Phase II Study Botulinum toxin type A, Placebo - Vulvodynia | Phase 2 | Terminated | Ipsen | 60 | 2018-06-11 | 2021-12-09 |
| A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia Capsaicin patch - Vestibulodynia | Phase 2 / Phase 3 | Terminated | Centre Hospitalier Universitaire de Besancon | 10 | 2016-01-20 | 2022-11-14 |
| A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia Bladder instillation with heparin/ lidocaine - Vulvodynia | Phase 2 | Withdrawn | Scripps Health | 2012-12-01 | 2022-11-22 | |
| Enoxaparin as Treatment for Vulvodynia Clexane (enoxaparin) - Vulvodynia | Phase 2 | Completed | Western Galilee Hospital-Nahariya | 40 | 2009-03-01 | 2020-05-20 |
| Pregabalin for the Treatment of Vulvodynia pregabalin - Vulvodynia, Vulvar Vestibulitis | Phase 2 | Terminated | The Cleveland Clinic | 16 | 2009-02-01 | 2021-07-19 |
| CC-10004 For The Treatment Of Vulvodynia CC-10004 - Vulvodynia | Phase 2 | Completed | Kenneth Peters, MD | 10 | 2008-12-01 | 2015-08-13 |
| Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort Lidocaine/Diphenhydramine, lidocaine, placebo - Vulvodynia | Phase 2 | Completed | Lumara Health, Inc. | 105 | 2007-10-01 | 2012-03-02 |
Pelvic Pain (3) · Cystitis, Interstitial (2) · Dyspareunia (2) · Back Pain (1) · Chronic Pain (1) · Endometriosis (1) · Fatigue Syndrome, Chronic (1) · Fibromyalgia (1) · Irritable Bowel Syndrome (1) · Migraine Disorders (1) · Sexual Dysfunctions, Psychological (1) · Temporomandibular Joint Disorders (1) · Tension-Type Headache (1) · Vulvar Lichen Sclerosus (1)
Female Urogenital Diseases (14) · Female Urogenital Diseases and Pregnancy Complications (14) · Genital Diseases (14) · Genital Diseases, Female (14) · Urogenital Diseases (14) · Vulvar Diseases (14) · Male Urogenital Diseases (4) · Neurologic Manifestations (3) · Pain (3) · Pathological Conditions, Signs and Symptoms (3) · Signs and Symptoms (3) · Cystitis (2) · Genital Diseases, Male (2) · Mental Disorders (2) · Sexual Dysfunction, Physiological (2)
Lidocaine (2) · Naltrexone (2) · Administration, Intravesical (1) · Botulinum Toxins, Type A (1) · Diphenhydramine (1) · Drug Evaluation (1) · Enoxaparin (1) · Estradiol (1) · Heparin (1) · Ketotifen (1) · Nortriptyline (1) · Petrolatum (1) · Pregabalin (1) · Testosterone (1) · Vaginal Creams, Foams, and Jellies (1)
Center for Vulvovaginal Disorders (1) · Centre Hospitalier Universitaire de Besancon (1) · Duke University (1) · GTO Pharmaceutical, LLC (1) · Initiator Pharma (1) · Ipsen (1) · Kenneth Peters, MD (1) · Lumara Health, Inc. (1) · Medical University of Lublin (1) · Scripps Health (1) · The Cleveland Clinic (1) · TriHealth Inc. (1) · University of Florida (1) · Western Galilee Hospital-Nahariya (1)
United States (10) · Canada (2) · France (1) · Israel (1) · Poland (1) · United Kingdom (1)
Abimbola Babajide, Dr (1) · Andrea Nackley, PhD (1) · Andrew T Goldstein, MD (1) · Beri M Ridgeway, MD (1) · Bruce Kahn, M.D. (1) · Fabien Pelletier, MD (1) · Jim Joffrion (1) · Kenneth M Peters, M.D. (1) · Lila Nachtigall, M.D. (1) · Matthew D Barber, MD, MHS (1)
PMID 22914465, PMID 36269028, PMID 39953376, PMID 40590401, PMID 42857927
R01HD096331 (1)