Trial Condition(s):

Dysmenorrhea,, Menorrhagia

Retrospective analysis in women with dysmenorrhea or heavy menstrual bleeding in Japan: A database study

Bayer Identifier:

18068

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Not Yet Recruiting

Trial Purpose

The purpose of this study is to evaluate the patient profiles, treatment patterns, and healthcare resource use and associated costs of patients with dysmenorrhea and heavy menstrual bleeding (HMB), using a secondary database.

Inclusion Criteria
Inclusion criteria for disease cohort cases:
 - Patients enrolled in health insurance societies contributing to JMDC claims database between July 1st, 2009 and June 30th, 2014
 - Women and Age at index date:  ≥18 and ≤49 
 - At least two consecutive diagnoses of dysmenorrhea/HMB, with the second diagnosis within 3 months from the index date.
 - No diagnosis of dysmenorrhea/HMB in the pre-index period, which is 6 months.
 - Patients enrolled in the health insurance plan for the 6index date and for at least 12 months after the index date.  

Inclusion criteria for the control group:
 - Patients who are enrolled in health insurance societies contributing to JMDC claims database between July 1st , 2009 and June 30th, 2014
 - Women Age ≥18 and ≤49 
 - Patients without any diagnosis with dysmenorrhea (in the analysis for dysmenorrhea) or HMB (in the analysis for HMB) between July 1st, 2009 and December 31st, 2013.
 - Patients enrolled who meet the study follow-up duration criteria for pre- and post-index period in JMDC database.
Exclusion Criteria
- At least one diagnosis of cancerous diagnosis,  cervical dysplasia, endometrial hyperplasia with atypia or endometrial intraepithelial neoplasia periods (Ref. ICD10: Annex 3.1).
 - At least one surgical procedure (hysterectomy, endometrial ablation, myomectomy,) embolization) during pre-index period (Ref. Procedure codes Annex 3.2). 
 - At least one diagnosis of bleeding disorder ( ((ICD10: D65-69 [Coagulation defects, purpura and other hemorrhagic conditions]) during pre- and post-index period.
 - At least one prescription of a hormonal treatment (LEP, progestin, testosterone derivatives, and GnRH analog) during pre-index period excluding 15 days before index date (Ref. drug list: Annex 3.5).

Trial Summary

Enrollment Goal
40
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Not yet recruiting
 

Trial Design