Not Yet Recruiting

Dysmenorrhea,, menorrhagia

Bayer Identifier:

18068

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Female

Age

18 - 49 Years

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

Trial Dates

June 2015 - October 2015

Phase

N/A

Could I Receive a placebo

Products

Unspecified

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Not yet recruiting		Many Locations, Japan

Primary Outcome

The date of diagnosis (index date) with dysmenorrhea / heavy menstrual bleeding
Time Frame:
Index date
Safety Issue:
No
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 - Myomectomy
Time Frame:
12 months post index date
Safety Issue:
No
time from diagnosis to initiation of medications, for each drug category(LEP,progestin, testosterone derivatives, GnRH analog, analgesic agents, hemostatis agents and TCM)
Time Frame:
12 months post index date
Safety Issue:
No
Time to treatment discontinuation
Time Frame:
12 months post index date
Safety Issue:
No
Time to treatment switch/combination
Time Frame:
12 months post index date
Safety Issue:
No
Time from index date to surgical procedure
Time Frame:
12 months post index date
Safety Issue:
No

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)
Time Frame:
12 months post index date
Safety Issue:
No
Diagnostic test (numbers of occurrences, by type of test)
Clinical test -Ultrasonic echo -CT scan -MRI Surgical test -Laparoscopy
Time Frame:
12 months post index date
Safety Issue:
No
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 -Adenomyosis
Time Frame:
12 months post index date
Safety Issue:
No

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

N/A

Additional Information

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