A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects

NCT02737852 | Completed Results

• 1 other identifier: ST-7609
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety of a new personal lubricant when used at least four times weekly for two weeks (including at least twice weekly during sexual intercourse for subjects with monogamous male partners), in a population consisting of healthy females.

Conditions

Erythema; Edema

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale

  Number of subjects with observed local erythema by obstetrician/gynecologist examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema

  2 weeks

• Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale

  Number of subjects with observed local edema by obstetrician/gynecologist examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema

  2 weeks

Study Arms (1)

Healthy subject

EXPERIMENTAL

Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks

Device: Trojan "Chameleon" Personal Lubricant

Interventions

Trojan "Chameleon" Personal Lubricant DEVICE

silicone base with sensate

Healthy subject

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• no participation in a similar study 2-weeks prior
• may be post-menopausal or have had a hysterectomy
• if sexually active, and of child bearing potential, subjects using adequate non-barrier method of birth control
• free from any vaginal disorders
• sexually active and monogamous, heterosexual relationship, and whose male partner is willing and able to give informed consent and agrees to engage in sexual intercourse at least twice each week during the two-week study or is not sexually active
• personal lubricant user and agrees to replace her usual personal lubricant with the investigational product
• can start regardless of where they are in their cycles
• agrees to use the provided investigational product at least four times weekly over the two week study period
• exhibits no clinically significant evidence of vulvar or vaginal irritation, as determined by a study doctor, and no reports of sensory irritation at the baseline exam
• willing to refrain from introducing any new vaginal products, or using vaginal medications or local contraceptives during study
• agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area
• willing to use a urine pregnancy test provided to them at baseline and on third visit
• standard medical history form on file
• signed informed consent
• completed HIPAA

You may not qualify if:

• pregnant, nursing or planning a pregnancy
• currently using or has used within two weeks prior to the study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories or antihistamines
• known allergies to vaginal or any cosmetic products
• reports history of recurrent bladder, vaginal infections or incontinence
• exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation
• uses a vaginal ring, diaphram or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception
• participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation
• receives a score higher than 0/5 for erythema, edema or \>0 for burning, stinging, or itching, during first examination or shows any other sign of mucosal irregularities

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

Clinical Research Laboratories, LLC

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Erythema; Edema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Annahita Ghassemi
• Organization: Church & Dwight Co., Inc

annhita.ghassemi@churchdwight.com

6098061200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The new personal lubricant was used by all participants
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 1, 2017
• Results First Posted: August 2, 2017

Record last verified: 2017-08

Locations

US (1)