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

NCT02320214 | Completed Results

• 1 other identifier: ST-7555
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety of Miami w/ frag Personal lubricant when used as indicated as a personal lubricant in the vagina and vulvar/perineal areas at least four times weekly for two weeks in a population of healthy females.

Conditions

Erythema; Edema

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Observed Local Erythema

  Number of participants with observed erythema by OB/GYN examination.

  14 Days

• Number of Participants With Observed Local Edema

  Number of participants with observed edema by OB/GYN examination.

  14 Days

Study Arms (1)

Miami w/ frag Personal lubricant

EXPERIMENTAL

Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.

Device: Miami w/ frag Personal lubricant

Interventions

Miami w/ frag Personal lubricant DEVICE

Miami w/ frag Personal lubricant

Eligibility Criteria

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

You may qualify if:

• Subject is female between the ages of 18 and 49 years (at lease 21 subjects) or 50-60 years (no more than 9 subjects);
• Subject is using adequate non-barrier method of birth control \[established us of hormonal methods of contraception (oral, injected, implanted, or patch), intrauterine device (IUD) or intrauterine system (IUS), surgical sterilization (e.g. in a monogamous relationship with male partner with vasectomy\];
• Subject is free of any vaginal disorders;
• Subject is sexually active and in a 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 (at least 50% and up to 100% of the study population) or is not sexually active (no more than 50% of the population);
• Subject is a personal lubricant user and agrees to replace her usual personal lubricant with the investigational product;
• Subject has normal menstrual cycle and is not expected to menstruate 2-4 days before or after the examination days;
• Subject agrees to use the provided investigational product at least four times weekly (including at least twice weekly during sexual intercourse for subjects with monogamous, male partners) over the two-week study period;
• Subject 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 examination;
• Subject is willing to refrain from introducing any new vaginal products, or using vaginal medication or local contraceptives (including condoms and hormonal rings), during the course of this study;
• Subject agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area for the duration of the study (Note: subjects may continue to use their usual pantyliner, if any);
• Subject is willing to use a urine pregnancy test provided to them at baseline and on the third visit (Week 2, day 14);
• Subject has signed and, if sexually active and in a monogamous relationship, whose partner has signed, an Informed Consent Form (ICF) in compliance with 21 CFR Part 50: "Protection of Human Subjects";
• Subject (and male partner, if applicable) has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
• Subject is dependable and able to follow directions as outlined in the protocol;
• Subject receives a score of 0 or 0.5 for erythema and edema, and 0 for sensorial irritation (burning, stinging, itching, and dryness) during the first examination.

You may not qualify if:

• Subject is pregnant, nursing, or planning a pregnancy;
• Subject is post-menopausal or has had a hysterectomy;
• Subject is currently using, or has used within two weeks prior to study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories, or antihistamines;
• Subject has known allergies to vaginal or any cosmetic products (including lotions, moisturizer, powder, sprays, etc.);
• Subject reports a history of recurrent bladder, vaginal infection, or incontinence;
• Subject exhibits or reports gynecological abnormalities or has had vaginitis within 60 days prior to study initiation.
• Subject is expected to menstruate 2-4 days before or after the time of the first, second, and third examination;
• Subject uses a vaginal ring, diaphragm or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception;
• Subject has participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation;
• Subject receives a score higher than 0.5 for erythema, edema, or \>0 for burning, stinging, or itching, during the first examination or shows any other sign of mucosal irregularities (dryness, papules, vesticulation, fissure).

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

Clinical Research Laboratories

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.

annahita.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
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 19, 2014
• Study Start: December 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 6, 2016
• Results First Posted: September 20, 2016

Record last verified: 2016-10

Locations

US (1)