NCT03272204

Brief Summary

This research study seeks to find if there is a connection between the presence of pubic hair and the type of bacteria that live in the vagina and bladder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

August 18, 2017

Last Update Submit

June 3, 2020

Conditions

Healthy

Keywords

pubic hair; grooming; urinary tract symptoms; vaginitis

Outcome Measures

Primary Outcomes (1)

  • Comparison of Urinary and Vaginal Microbiomes

    Describe and compare the urinary and vaginal microbiome in the same woman with natural pubic hair and with fully removed pubic hair

    up to 3 months

Secondary Outcomes (3)

  • Questionnaire Comparison

    up to 3 months

  • Self-Reported Infections

    up to 3 months

  • Subtracting Microbiome Results

    up to 3 months

Study Arms (2)

Natural Pubic Hair

OTHER

Participant with natural hair crosses over to removed pubic hair

Behavioral: No pubic hair

Removed Pubic Hair

OTHER

Participant with no pubic hair crosses over to natural pubic hair

Behavioral: Pubic Hair

Interventions

No pubic hairBEHAVIORAL

Natural pubic hair to fully removed pubic hair

Natural Pubic Hair
Pubic HairBEHAVIORAL

Removed pubic hair to natural pubic hair

Removed Pubic Hair

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pre-menopausal women between the ages of 18-50
  • English-speaking
  • Women with either natural growth/distribution of pubic hair or complete removal of pubic hair through a reversible process.
  • Women who do not feel they have urinary or vaginal health problems and are not seeking care for these issues
  • Women must be willing and able to complete study documentation and study procedures.

You may not qualify if:

  • Hair has been removed through an irreversible process like laser or electrolysis
  • Patient feels they have bothersome urinary or pelvic floor conditions for which they are seeking care (for example: vaginal prolapse, frequent urinary incontinence, chronic pelvic pain, bladder pain)
  • Patient plans on having any type of surgery in the next 2 months (due to likely antibiotic use)
  • Patient has a history of a transplant and is on immunosuppression
  • Patient has cancer for which she is currently getting chemotherapy or radiation
  • Currently taking or has taken antibiotics in the last 7 days for any reason
  • Patient has symptoms of a urinary tract or vaginal infection or is found on exam or culture to have a urinary tract infection or vaginal infection
  • Patient is pregnant or breastfeeding
  • Patient has douched in the last 48 hours
  • Patient has had intercourse in the last 48 hours
  • Patient is currently menstruating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Geynisman-Tan J, Kenton K, Tavathia M, Yee A, Gilbert JA, Collins S, Lewicky-Gaupp C, Mueller M. Bare Versus Hair: Do Pubic Hair Grooming Preferences Dictate the Urogenital Microbiome? Female Pelvic Med Reconstr Surg. 2021 Sep 1;27(9):532-537. doi: 10.1097/SPV.0000000000000968.

    PMID: 33181518DERIVED

MeSH Terms

Conditions

GroomingVaginitis

Condition Hierarchy (Ancestors)

Appetitive BehaviorBehavior, AnimalBehaviorVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Margaret G Mueller, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Obstetrics and Gynecology, Urology

Study Record Dates

First Submitted

August 18, 2017

First Posted

September 5, 2017

Study Start

October 1, 2017

Primary Completion

June 14, 2019

Study Completion

June 14, 2019

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations

US(1)