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
EU CT 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
Phase
N/A
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Japan | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Retrospective analysis of patient profiles, treatment pathways, healthcare resource utilisation and costs in women with dysmenorrhea or heavy menstrual bleeding in Japan: A database study using reimbursement claims
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
3
Primary Outcome
- The date of diagnosis (index date) with dysmenorrhea / heavy menstrual bleedingTimeframe: Index date
- Type of treatment used (covered by the government-provided health insurance<The following are for types of treatments used> Drug category: - Low-dose estrogen progestin hormonal combination (LEP) - Ethinylestradiol Betadex - Norethisterone, Ethinylestradiol - Progestin - Dienogest - Testosterone derivatives - Danazol - GnRH analog - Buserelin acetate - Goserelin acetate - Leuprorelin acetate - Analgesic agents - NSAIDs - Hemostasis agents - Tranexamic acid - Carbazochrome sodium sulfonate hydrate - Traditional Chinese medicine(Kampo) - Toki-shakuyaku-san (Tsumura TJ-23 or equivalent) - Kami-shoyo-san (Tsumura TJ-24 or equivalent) - Keishi-Bukuryo-gan (Tsumura TJ-25 or equivalent) Surgical procedures: - Hysterectomy - Uterine preservation surgery - Endometrial ablation - MyomectomyTimeframe: 12 months post index date
- time from diagnosis to initiation of medications, for each drug category(LEP,progestin, testosterone derivatives, GnRH analog, analgesic agents, hemostatis agents and TCM)Timeframe: 12 months post index date
- Time to treatment discontinuationTimeframe: 12 months post index date
- Time to treatment switch/combinationTimeframe: 12 months post index date
- Time from index date to surgical procedureTimeframe: 12 months post index date
Secondary Outcome
- Healthcare resource utilization-Inpatients admissions (number of stays, cumulative length of stay) -Outpatient visits (number of visits) -Emergency department visits (number of visits)Timeframe: 12 months post index date
- Diagnostic test (numbers of occurrences, by type of test)Clinical test -Ultrasonic echo -CT scan -MRI Surgical test -LaparoscopyTimeframe: 12 months post index date
- Direct medical costs associated with dysmenorrhea/heavy menstrual bleedingfor post-index period (to be extracted from the database) for one year from index date.-Total medical cost -Inpatient cost -Outpatient cost -Pharmacy cost -Diagnostic cost -Underlying conditions -Endometriosis -Uterine Fibroids -AdenomyosisTimeframe: 12 months post index date
Additional Information
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