NCT00397202

Brief Summary

  1. 1.Purpose: To compare the use of the menstrual cup "The DivaCupTM " to a menstrual strategy using tampons as the primary method of menstrual flow management using indicators of user-satisfaction, urinary tract infection, vaginal irritation, cost and waste.
  2. 2.Hypothesis: The "The DivaCupTM" will have similar rates of user-satisfaction, urinary tract infection, and vaginal irritation as a menstrual strategy using tampons as the primary method of menstrual flow management but will likely be more reasonable in terms of cost and will generate less waste.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

November 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

2.6 years

First QC Date

November 6, 2006

Last Update Submit

April 29, 2015

Conditions

Menstruation

Keywords

Menstruation

Outcome Measures

Primary Outcomes (1)

  • Overall satisfaction with menstrual strategy.

Secondary Outcomes (5)

  • Diagnosed UTI

  • Diagnosed vaginitis

  • Vaginal irritation

  • Waste

  • Cost

Study Arms (1)

The DivaCupTM

ACTIVE COMPARATOR
Device: Diva Cup TM

Interventions

Diva Cup TMDEVICE

See Detailed Description.

The DivaCupTM

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women between the ages of 19 and 40 who have menstrual flow most months and who currently self-identify as using tampons as their primary method of menstrual management

You may not qualify if:

  • Have a sensitivity or allergy to silicone
  • Have an active vaginal or urogenital infection
  • Are pregnant, or who have plans to become pregnant before spring 2007 (end of study data collection)
  • Have used systemic antimicrobials within the previous 14 days
  • Are unable to understand the nature and purpose of the study
  • Are unable to understand and express themselves in written and spoken English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private family physician offices

Victoria, Vancouver, Prince George, British Columbia, Canada

Location

Related Publications (1)

  • Howard C, Rose CL, Trouton K, Stamm H, Marentette D, Kirkpatrick N, Karalic S, Fernandez R, Paget J. FLOW (finding lasting options for women): multicentre randomized controlled trial comparing tampons with menstrual cups. Can Fam Physician. 2011 Jun;57(6):e208-15.

    PMID: 21673197DERIVED

Study Officials

  • Konia Trouton, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2006

First Posted

November 8, 2006

Study Start

November 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2011

Last Updated

April 30, 2015

Record last verified: 2015-04

Locations

CA(1)