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
Effectiveness Progress
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
Safety Progress
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.
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Conditions
Cancer Related
Treatments