Clinical trials: Pessary
Pelvic Organ Prolapse, Prolapse
Early Feasibility Study of the Reia Vaginal Pessary
This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse…
- Trial name
- NCT04275089
- Testing
- Reia Vaginal Pessary
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Reia, LLC
Bacterial Vaginosis
Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis
This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed bacterial vaginosis (BV) according to fulfillment of at least 3…
- Trial name
- NCT03762083
- Testing
- pHyph generation I
- Where
- 2 sites in Sweden
- Volunteers
- 24 people
- Sponsor
- Gedea Biotech AB
Stress Urinary Incontinence
Pippa Pessary Study (Clinical Trial)
This is an open label, interventional, single arm, multi-clinic study where each adult female participant with stress urinary incontinence (SUI) serves as her own control (vaginal pessary use vs. no vaginal pessary).
- Trial name
- NCT05611970
- Testing
- Vaginal pessary
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Liv Labs Inc.
Vulvovaginal Candidiasis
Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of…
- Trial name
- NCT00803738
- Testing
- Terconazole Vaginal Suppository, Terazol Vaginal Suppository
- Volunteers
- 572 people
- Sponsor
- Padagis LLC
Stress Urinary Incontinence (SUI)
A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)
This study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 80 women with SUI.
- Trial name
- NCT02131311
- Testing
- disposable, single-use pessary
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- Procter and Gamble
Pelvic Organ Prolapse
Feasibility Study of the Reia Vaginal Pessary
The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal pessary design for the use in women who suffer from symptoms of pelvic organ…
- Trial name
- NCT04508335
- Testing
- Reia Vaginal Pessary
- Where
- 7 sites in United States
- Volunteers
- 78 people
- Sponsor
- Reia, LLC
Stress Urinary Incontinence
A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence
This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.
- Trial name
- NCT02160314
- Testing
- pessary, Absorbent pad
- Where
- United States
- Volunteers
- 224 people
- Sponsor
- Procter and Gamble
Vulvovaginal Candidiasis
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic…
- Trial name
- NCT01144286
- Testing
- arasertaconazole nitrate
- Where
- Spain
- Volunteers
- 229 people
- Sponsor
- Ferrer Internacional S.A.
Ulcerative Proctitis
Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories
A randomized, multi-center, double-blind, three arm placebo-controlled study in male and non-pregnant, non-lactating female subjects aged 18 years to examine the safety and efficacy of two dosing regimens of hydrocortisone…
- Trial name
- NCT04469686
- Testing
- Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
- Where
- 189 sites in United States, Bulgaria and 21 more
- Volunteers
- 200 people
- Sponsor
- Cristcot HCA LLC
Stress Urinary Incontinence
Disposable Stress Urinary Incontinence Pessary Device Study
This study is an interventional, single arm, multi-center study. It will be conducted at sites in the northeastern United States. The protocol will be approved by Chesapeake IRB or applicable local IRBs.
- Trial name
- NCT03323723
- Testing
- SUI Device
- Where
- 3 sites in United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Rinovum Women's Health, Inc.
Proctitis, Ulcerative
Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and…
- Trial name
- NCT01016262
- Testing
- MAX-002, Canasa®
- Where
- 40 sites in United States, Canada and 1 more
- Volunteers
- 119 people
- Sponsor
- Forest Laboratories
Preterm Birth
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 weeks and 6 days) and 34…
- Trial name
- PCP002 (NCT02225353)
- Testing
- Progesterone Cervical Pessary 6.3 g, Progesterone 200 mg vaginal capsules, Progesterone Cervical Pessary 7.7 g
- Where
- 4 sites in Chile
- Volunteers
- 271 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Fecal Incontinence, Bowel Dysfunction
LIBERATE - PRO: Eclipse™ System Registry
A prospective, open label post market registry to collect Patient Reported Outcomes in an online data capture registry, maintained by Pelvalon, of women with fecal incontinence exiting the LIBERATE study (NCT02428595) continuing…
- Conditions
- Fecal Incontinence, Bowel Dysfunction, Bowel Incontinence, Accidental Bowel Leakage
- Trial name
- LIBERATEPRO (NCT03028636)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Pelvalon, Inc.
Vulvovaginal Candidiasis
Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
This is a multi-centre, multi-national study to evaluate the clinical performance and safety of treatment with Gedea Pessary in adult women with confirmed vulvovaginal candidiasis (VVC).
- Trial name
- EpHect (NCT05507333)
- Testing
- pHyph generation II
- Where
- 4 sites in Sweden
- Volunteers
- 26 people
- Sponsor
- Gedea Biotech AB
Internal Hemorrhoids
Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids
A randomized, double-blind, placebo-controlled, multicenter, parallel group study of the safety and efficacy of Hydrocortisone Acetate Suppositories, 25 mg compared to placebo suppositories in the treatment of symptomatic…
- Trial name
- NCT03335774
- Testing
- Hydrocortisone Acetate Suppository, 25 mg (Nivagen)
- Where
- 2 sites in United States, India
- Volunteers
- 103 people
- Sponsor
- Nivagen Pharmaceuticals Inc.
Vulvovaginal Candidiasis
Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis
This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with vulvovaginal candidias (VVC).
- Trial name
- NCT03761628
- Testing
- pHyph generation I
- Where
- 2 sites in Sweden
- Volunteers
- 24 people
- Sponsor
- Gedea Biotech AB