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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022779
Receipt No. 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 2017/12/28

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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
Obsterics 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
Email 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
Email tani4327@grape.med.tottori-u.ac.jp

Sponsor
Institute Tottori University Hospital
Institute
Department

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
Email

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
2017 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026116

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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