ErythemaNCT02320227

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

A study testing Miami w/o frag Personal lubricant in people with Erythema and Edema, run by Church & Dwight Company, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety of a 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 Read more about this study

Who is it for?: Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Erythema, Edema
What is being tested?: Miami w/o frag Personal lubricant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Dec 2014to Jan 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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;

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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 a standard Clinical Research Laboratories, Inc. (CRL) Medical History form on file at CRL and has completed study specific Medical History and Screener/Inclusion forms;
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.

Who cannot join

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.

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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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Research Laboratories
Piscataway, New Jersey, 08854

Other trials in United States

About this study

Conditions: Erythema, Edema
Being tested: Miami w/o frag Personal lubricant
Medical subject headings: Erythema, Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Miami w/o frag Personal lubricantDevice

Study groups in NCT02320227
Study group	Role	What they receive
Miami w/o frag Personal lubricant	Experimental	Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks Receives: Device: Miami w/o frag Personal lubricant

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Observed Local Erythema
Number of participants with observed local erythema by OB/GYN examination.
Measured: 14 Days
Number of Participants With Observed Local Edema
Number of participants with observed edema by OB/GYN examination.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Jan 2015

First posted19 Dec 2014 (estimated)
Study startDec 2014
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ErythemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02320227
Sponsor's protocol ID: ST-7557
Status last verified: Jan 2017
First submitted: 9 Dec 2014
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Erythema trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Clinical Study to Evaluate the Safety of a Non-Fragranced Personal Lubricant in Healthy Female Subjects
ClinicalTrials.gov ID: NCT02320227
Acronym / sponsor ID: ST-7557
Conditions: Erythema, Edema
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 19 Dec 2014 (estimated)
Results: Posted 12 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Miami w/o frag Personal lubricant	Experimental	Device: Miami w/o frag Personal lubricantHealthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (16 listed)

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;

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Miami w/o frag Personal lubricant	Device	Miami w/o frag Personal lubricant

Primary outcome

Number of Participants With Observed Local Erythema
Time frame: 14 Days
Number of participants with observed local erythema by OB/GYN examination.
Number of Participants With Observed Local Edema
Time frame: 14 days
Number of participants with observed edema by OB/GYN examination.

Results and safety

Results posted to the registry on 12 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Healthy Subjects	30	30

Primary outcome: Number of Participants With Observed Local Erythema

Time frame: 14 Days. Number. Unit: participants

Measure	Miami w/o Frag Personal Lubricant n = 30
Value	0

Primary outcome: Number of Participants With Observed Local Edema

Time frame: 14 days. Number. Unit: participants

Measure	Miami w/o Frag Personal Lubricant n = 30
Value	0

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: Healthy Subjects	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Erythema

RecruitingPhase 2
Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction
Erythema Nodosum Leprosum
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Not yet recruiting
The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Facial Erythema and Other Skin Parameters
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RecruitingObservational study
Autologous Hair Follicle Derived Secretome as Adjunct to Aesthetic Procedures
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Miami w/o frag Personal lubricant in people with Erythema and Edema, run by Church & Dwight Company, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Observed Local Erythema (time frame: 14 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02320227.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.