CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 353 enrolled
Drug / intervention
cyclic microgestin 1/20 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02214550
NCT02214550Phase 4Completed
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Deciphering the Hormonal and Nociceptive Mechanisms Underlying Bladder Pain

Endeavor Health·interventional·Posted Aug 12, 2014·Updated Jun 18, 2023

In Brief

A Phase 4 clinical trial evaluating cyclic microgestin 1/20 and continuous microgestin 1/20 for Cystitis, Interstitial and 6 related conditions. Completed, enrolled 353 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if some women with dysmenorrhea (painful periods) are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives (OC) can be used to reverse this chronic pain risk. Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ sensitization (COS) episodes. The use of cyclical OCs to eliminate dysmenorrhea is expected to reduce COS and decrease the risk of developing CPP.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystitis, Interstitial, Dysmenorrhea, Migraine Disorders, Pelvic Pain, Endometriosis, Visceral Pain, Chronic Pain
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 12, 2014
Enrollment StartJul 1, 2014
Primary CompletionNov 1, 2020
Study CompletionJan 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 11.9 years ago

Interventions

cyclic microgestin 1/20drug

Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat

continuous microgestin 1/20drug

Continuous OC use - Pills containing hormones will be taken every day for 1 year