Phase 4 N=353 Randomized Single-blind Treatment

Chronic Pain Risk Associated With Menstrual Period Pain

Cystitis, Interstitial · Dysmenorrhea · Migraine Disorders · Pelvic Pain · Endometriosis

Bottom Line

View on ClinicalTrials.gov: NCT02214550 ↗

Enrolled (actual)

353

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: Change in Participant Bladder Pain Sensitivity From Baseline. — 38.2; 37.0; 41.2; 47.9 score on a scale — p=.02

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: cyclic microgestin 1/20 (Drug); continuous microgestin 1/20 (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Endeavor Health
Primary completion: Nov 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Participant Bladder Pain Sensitivity From Baseline.	38.2; 37.0; 41.2; 47.9; 2.2; 17.3	.02 sig
SECONDARY Change in Quantitative Sensory Testing (QST) Parameters Regarding Pelvic Hyperalgesia From Baseline	5.95; 9.38; 13.8; 8.21; 11.6; 6.9	0.2315
SECONDARY Differences in EEG Recorded Cortical Activity Among Participants	10.03; 10.0; 10.05; 10.13; 10.03; 10.15	.393

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.

Eligibility Criteria

Inclusion Criteria

All

Reproductive age women (18-45)

For dysmenorrhea and D+COS group only:

Participants must have had regular (22-45 day) menstrual cycles over at least a two month period preceding testing

Exclusion Criteria

All

presence of active pelvic or abdominal malignancies (primary or metastatic)
active genitourinary infection in the last four weeks
unable to read or comprehend the informed consent in English
unwilling to undergo pelvic examination/testing
presence of hypertension or risk for developing hypertension, and

For dysmenorrhea and D+COS group only:

absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding) unwilling to take either cyclic or combined OCs
unwilling to withdraw from OCs for two months prior to the sensory testing study visit.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02214550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.