Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04885556
Other study ID # AC-004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 5, 2021
Est. completion date September 15, 2021

Study information

Verified date May 2021
Source Atlantic Health System
Contact Cynthia Evaniecki
Phone 973-537-5557
Email cevaniecki@gsunj.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Previous research has shown that semen deposition in the vagina after intercourse leads to dripping, discomfort, and vaginal odor. This study is evaluating a hygiene device designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal to determine if there is a reduction in dripping and odor, and to determine the amount of fluids absorbed.


Description:

Despite the significant number of sexual dysfunctions in women, physicians often avoid discussing these concerns in the office setting. With recent research on the role of the pelvic floor, and recently approved medical therapies for hypoactive sexual desire disorder, physicians have begun to adapt to questioning patients about libido and pain-related sexual dysfunctions. However, pain-related sexual questionnaires often focus on insertional and penetrational dyspareunia, without asking about discomfort minutes, hours, or even the day following sexual intercourse. One common compliant in ambulatory sexual medicine clinics is the bothersome dripping, odor, and discomfort women experience after sexual activity when no condom is used, and when intravaginal ejaculation occurs. Previous studies have shown the effects of semen on alterations in the vaginal flora. These changes contribute to a multitude of clinical complaints and diagnoses, including malodor, continuous discharge after intercourse, and bacterial vaginosis (BV). The exposure of semen changes the vaginal flora by increasing the pH levels, in turn altering the bacterial growth pattern. This implies the persistent presence of semen in the vagina may be one of the causes of malodor and development of BV. Chvapil utilized gas chromatography and demonstrated that the longer period of time semen was present in the vagina, the more likely it resulted in a strong and unattractive vaginal odor. Gallo showed that an incidental diagnosis of BV was correlated with detection of sperm on gram stain, and frequent coitus with or without condom use. The investigator's goal in this study is to evaluate a novel postcoital consumer health product and its effects on the complaints of continuous seepage of semen and vaginal odor after intercourse.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 15, 2021
Est. primary completion date September 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria: - Heterosexual - Age 25-50 - Has used tampons in the past 5 years - Sexually active (vaginal intercourse, minimum once per week) - Answered "moderate" to "severe" to being bothered by dripping/discomfort on Patient Global Impression of Severity (PGI-S) questionnaire "on minutes, hours, or following day" - Willing and able to use product - Understands, reads, writes, and speaks English Exclusion Criteria: - Pregnant - Currently using condoms - Unable to use device due to poor motor function - Chronic disease which makes prone to infection (diabetes, autoimmune) - Recurrent yeast infections - Recurrent Urinary tract infection (UTI) (>2 within the past year) - Diagnosis of pelvic organ prolapse (Stage II or greater) - Previous pelvic or vaginal surgery which, in the opinion of the investigator, may prevent proper use of product - Unable to sign informed consent

Study Design


Intervention

Device:
Tampon-like device for absorption of sexual fluids
Subjects will insert a tampon-like device to absorb sexual fluids after intercourse

Locations

Country Name City State
United States The Center for Specialized Women's Health, division of Garden State Urology Denville New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Global Impression of Improvement (PGI-I) Validated Questionnaire within 1 hour of use of product
Primary Weight of Investigational Device Product weight (amount of fluid absorbed) within 1 hour of use of product
See also
  Status Clinical Trial Phase
Completed NCT03935698 - Physiotherapy Treatment in Women With Dyspareunia Following Gynecological Cancer: a Pilot Study N/A
Recruiting NCT03427255 - CBT Group Treatment for Women With Dyspareunia N/A
Completed NCT02253173 - Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women Phase 3
Completed NCT03184077 - Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair N/A
Recruiting NCT05445115 - The Mollie Study, a Study to Evaluate the Safety and Efficacy of the Mollie Medical Device N/A
Withdrawn NCT03666819 - Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy Phase 2
Active, not recruiting NCT03681678 - Laser Therapy for Treatment of Urogenital Symptoms in Women
Completed NCT04955418 - Effects of Epi-no Device on Pelvic Floor Dysfunctions N/A
Completed NCT05834088 - Effects of Myofascial Release With and Without Thiele Massage N/A
Terminated NCT03185169 - GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors Early Phase 1
Completed NCT03307044 - Fractional CO2 Laser Therapy for Survivors of Breast Malignancies N/A
Completed NCT05617820 - Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy Phase 3
Recruiting NCT03714581 - Laser Therapy Following Radiotherapy for Gynecological Cancer N/A
Completed NCT04659668 - Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina. N/A
Completed NCT03199534 - A Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction Phase 4
Completed NCT00318500 - Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women Phase 2
Recruiting NCT05540353 - Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients With Endometriosis. N/A
Completed NCT03178825 - Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause N/A
Completed NCT04389489 - Postpartum Sexual Function in Pregnant Women With COVID-19
Completed NCT03372720 - Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors N/A