UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022779 |
|---|---|
| Receipt number | R000026116 |
| Scientific Title | Clinical trial of the efficacy and safety of dydrogesterone in dysmenorrhoea patients. |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2021/10/30 18:55:48 |
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Basic information
Public title
Clinical trial of the efficacy and safety of dydrogesterone in dysmenorrhoea patients.
Acronym
Clinical trial of dydrogesterone in dysmenorrhoea patients.
Scientific Title
Clinical trial of the efficacy and safety of dydrogesterone in dysmenorrhoea patients.
Scientific Title:Acronym
Clinical trial of dydrogesterone in dysmenorrhoea patients.
Region
| Japan |
Condition
Condition
Dysmenorrhoea
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of
dydrogesterone in patients with dysmenorrhea.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Valuation of total dysmenorrhea score.
Key secondary outcomes
VAS of pain by dysmenorrhea,
dysmenorrhea score,
objective,
adverse experience
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The oral administration twice a day for 21 days. This cycle is repeated four times.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
1. Patients with diagnosis of primary or secondary dysmenorrhea.
2. The menstrual cycle is 28 plus or minus 3 days.
3. The total number of the dysmenorrhea score is three points or more at the time of registering.
Key exclusion criteria
1. Patients with medical history of serious liver failure or liver disease.
2. Patients with medical history of heart disease or kidney disease
3. Patients with porphyria.
4. Patients with medical history of peptic ulceration.
5. Patients with severe abnormal clinical examination.
6. Patients with asthma bronchial or asthma aspirin-sensitive.
7. Patients with colitis ulcerative or Crohn's disease.
8. Treatment with luteal hormone or follicular hormone-based hormone agents, low dose pill, middle dose pill, GnRH agonist, testosterone derivative, follicular hormone antagonist, aromatase inhibitor, Chinese herbal medicine for dysmenorrhea or within 2 months of initiation of administration
9. Treatment with transvaginal alcohol fixative, surgical therapy by laparotomy or laparoscope within 2 months of initiation of administration.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tasuku Harada |
Organization
Tottori University Hospital
Division name
Division of Reproductive-Perinatal Medicine and Gynecologic Oncology
Zip code
Address
36-1 Nishicho, Yonago, Tottori
TEL
0859-38-6641
tasuku@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuminori Taniguchi |
Organization
Tottori University Hospital
Division name
Division of Reproductive-Perinatal Medicine and Gynecologic Oncology
Zip code
Address
36-1 Nishicho, Yonago, Tottori
TEL
0859-38-6647
Homepage URL
http://obgyn.med.tottori-u.ac.jp/index.html
tani4327@grape.med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
Mylan EPD G.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
鳥取大学医学部附属病院（鳥取県）、倉敷平成病院（岡山）、鳥取赤十字病院（鳥取県）、松江生協病院（島根県）、島根県立中央病院（島根県）たがしらレディースクリニック（島根県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 13 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 05 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 17 | Day |
Last modified on
| 2021 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026116
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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