Clinical trials: Pessary
Hemorrhoidal Disease
A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 2 Study to Evaluate the Safety and Efficacy of Two Dosage Regimens of a Novel Hydrocortisone Acetate Suppository Formulation Administered With a Proprietary Suppository Applicator in Subjects With Hemorrhoidal Disease
The goal of this clinical trial is to evaluate the efficacy of two dosage regimens of hydrocortisone acetate suppository administered with a proprietary suppository applicator (Study Drug) compared to placebo in the treatment of…
- Trial name
- NCT07909291
- Testing
- hydrocortisone acetate 50 mg, hydrocortisone acetate 75 mg, proprietary suppository applicator
- Volunteers
- 78 people
- Sponsor
- Cristcot LLC
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
Pelvic Organ Prolapse, Prolapse
POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring…
- Trial name
- POMEGRANATE (NCT06634459)
- Testing
- Reia System, Standard of Care Pessary
- Where
- 9 sites in United States
- Volunteers
- 218 people
- Sponsor
- Medstar Health Research Institute
Use of Pessary Reduce the Number of Prolapse Recurrence, Uterine Prolapse
The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse
Genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or cystocele or rectocele, or mixed. About half of them will require surgical repair for the prolapse, with or without hysterectomy.
- Conditions
- Use of Pessary Reduce the Number of Prolapse Recurrence, Uterine Prolapse, Cystocele, Rectocele
- Trial name
- pfgp (NCT03056586)
- Testing
- vaginal pessary
- Volunteers
- 100 people
- Sponsor
- Meir Medical Center
Feeding Intolerance
Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants
Feeding intolerance is a common problem in preterm infants.
- Trial name
- NCT02149407
- Testing
- Glycerin, Rectal stimulation, Control
- Where
- 2 sites in Saudi Arabia
- Volunteers
- 230 people
- Sponsor
- King Saud Medical City
Pelvic Organ Prolapse
3D Translabial Ultrasound for Pessary Size Estimation
This is a feasibility study looking at the use of 3D ultrasound with vaginal manometry at various distension volumes to predict the best available pessary for successful fit.
- Trial name
- NCT03955744
- Testing
- 3D translabial ultrasound
- Where
- Canada
- Volunteers
- 21 people
- Sponsor
- Western University, Canada
Postoperative Pain
Impact of Placement of a Diazepam Suppository on Early Postoperative Pain Following Pelvic Reconstructive Surgery
This is a randomized double-blinded placebo controlled trial to examine the use of rectal diazepam suppositories after major vaginal pelvic organ prolapse surgery will decrease postoperative pain in the interval between 3.5 and 6…
- Trial name
- NCT04198233
- Testing
- Diazepam
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- TriHealth Inc.
Pelvic Organ Prolapse
R&D Supporting Pilot Study for the Assessment of the Safety and Effectiveness of the ProVATE (ProTIPI) Vaginal Pessary
The study includes five (5) main stages: Screening, Enrollment, Size fitting, Usage and Termination. Subject screening will be held during visit one (1) and visit two (2) at the clinic.
- Trial name
- NCT02239133
- Testing
- ProVATE vaginal pessary
- Where
- 3 sites in Israel
- Volunteers
- 44 people
- Sponsor
- ConTIPI Medical
Vulvovaginal Candidiasis, Genital
Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis
The purpose is to study superior efficacy of combination of Natamycin and Lactulose (Natamycin 100 mg + Lactulose 300 mg vaginal suppositories) compared to Pimafucin (Natamycin 100 mg vaginal suppositories), or Lactulose 300 mg…
- Trial name
- NCT06411314
- Testing
- Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories, Lactulose 300 mg vaginal suppositories, Pimafucin® (natamycin) 100 mg vaginal suppositories
- Where
- Russia
- Volunteers
- 218 people
- Sponsor
- Avva Rus, JSC
Infection, Prostatic Diseases
A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
To assess the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy
- Conditions
- Infection, Prostatic Diseases, Misadventure During Aspirating Needle Biopsy
- Trial name
- NCT02245334
- Testing
- Povidone-Iodine
- Where
- South Korea
- Volunteers
- 1,578 people
- Sponsor
- Seoul National University Hospital
Pain
Effects of Perioperative B&O Suppositories on Post-op Pain and Morphine Use After Laparoscopic Prostatectomy
This study is evaluating the effect of a Belladonna and Opium suppository administered intraoperatively on post operative pain after laparoscopic radical prostatectomy for prostate cancer. This is a blinded randomized study.
- Trial name
- NCT00863928
- Testing
- belladonna 16.2 mg and opium 60 mg suppository
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Benaroya Research Institute
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.
Cervical Insufficiency, Preterm Birth
Investigation Into the Microorganisms in Pregnant Women
Pregnant women with short cervical length (<25 mm) in second-trimester ultrasonographic assessment are at high risk for preterm birth, a major cause of perinatal mortality and morbidity worldwide.
- Trial name
- NCT04688866
- Testing
- Sequencing
- Where
- Hong Kong
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong
Genitourinary Syndrome of Menopause
Zinc Containing Vaginal Topical " Suppository "
The genitourinary syndrome of menopause (GSM) is a new term that describes various menopausal symptoms and signs associated with physical changes of the vulva, vagina, and lower urinary tract.
- Trial name
- NCT05453227
- Testing
- Zinc
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Egymedicalpedia
Human Immunodeficiency Virus, Human Papillomavirus
Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya
The objective of this randomized, placebo-controlled trial is to evaluate whether intravaginal artesunate pessaries (vaginal inserts) can be used as adjuvant therapy following thermal ablation to improve Human papillomavirus…
- Conditions
- Human Immunodeficiency Virus, Human Papillomavirus, Cervical Precancer
- Trial name
- NCT06519994
- Testing
- Artesunate vaginal inserts
- Where
- Kenya
- Volunteers
- 120 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Pelvic Organ Prolapse
Enabling Self-Care for Pessary Users in Rural Setting
This study is to see if a using new collapsible pessary (Reia pessary) for treatment of pelvic organ prolapse will allow patients to care for their prolapse on their own, rather than having to come to be seen by a provider in the…
- Trial name
- ESCAPE (NCT07084818)
- Testing
- Reia System pessary self-care management, Standard pessary office-based management
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Twin Pregnancy
Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG (EPEGE)
Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea
- Trial name
- EPEGE (NCT00502190)
- Testing
- Silicon ring positioned in the vagina, around the cervix
- Where
- France
- Volunteers
- 220 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Bowel Preparation
Effectiveness of Bisacodyl Suppository Agent for Dose Reduction of Low Dose PEG
Proper bowel cleansing before colonoscopy is an important factor to increase the detection rate of lesions. Low volume polyethylene glycol (PEG) plus ascorbic (PEG-Asc) has reduced the dosage of previous bowel preparation agent…
- Trial name
- NCT03849196
- Testing
- 2L PEG-Asc, Bisacodyl 10Mg Suppository, 1L PEG-Asc
- Where
- South Korea
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
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