Treatment for Menstrual Cup

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Menstrual Cup+1 More
Eligibility
18 - 45
Female
What conditions do you have?
Select

Study Summary

This trial will study if and how menstrual cups may cause IUDs to be displaced. The investigator hypothesizes that breaking the seal when inserting or removing the cup will result in a 15% rate of IUD displacement/expulsion.

Eligible Conditions
  • Menstrual Cup
  • Intrauterine Device (IUD) Complications, Mechanical.

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 12-18 months

12-18 months
III. The proportion of subjects who report feeling suction during menstrual cup removal.
III. The proportion of subjects who report palpating the IUD strings during menstrual cup removal.
III. The proportion of subjects who report pulling on the menstrual cup stem before breaking the seal.
The rate of IUD displacement measured by the frequency of IUDs that shift >1cm after manufacturer-recommended menstrual cup insertion and removal followed by insertion and removal the menstrual cup without breaking the seal.
Hip Dislocation

Trial Safety

Trial Design

0 Treatment Group

80 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12-18 months

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,591 Previous Clinical Trials
1,927,183 Total Patients Enrolled
Cara Clure, MDPrincipal InvestigatorUniversity of Colorado, Denver

Eligibility Criteria

Age 18 - 45 · Female Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are present at the clinic for IUD removal.\n
You are between the ages of 18-45.