UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059653 |
|---|---|
| Receipt number | R000068236 |
| Scientific Title | Multicenter Study on the Effects of an Estetrol-Containing Low-Dose Combined Oral Contraceptive on Bone Metabolism in Young Women |
| Date of disclosure of the study information | 2025/11/15 |
| Last modified on | 2025/11/05 21:28:23 |
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Basic information
Public title
E4-YBONE Study: Estetrol and Bone Metabolism in Young Women
Acronym
E4-YBONE Study
Scientific Title
Multicenter Study on the Effects of an Estetrol-Containing Low-Dose Combined Oral Contraceptive on Bone Metabolism in Young Women
Scientific Title:Acronym
E4-YBONE Study
Region
| Japan |
Condition
Condition
Dysmenorrhea
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of an E4-containing LEP formulation on bone metabolism in young women.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Longitudinal change in bone mineral density and bone quality (DXA)
Key secondary outcomes
Changes in bone metabolic markers (Tracp-5b, P1NP, IGF-I, etc.), and occurrence of adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients diagnosed with dysmenorrhea
Female patients aged 15 to 22 years who are at least 3 years after menarche
Patients who can provide written informed consent
Key exclusion criteria
Patients with a history of treatment with low-dose estrogen-progestin preparations for dysmenorrhea
Patients with a history of treatment with hormonal agents other than LEP preparations
Patients with a history of treatment with bone metabolism drugs
Patients with contraindications to estetrol-containing low-dose LEP preparations
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | SHIN |
| Middle name | |
| Last name | SAITO |
Organization
Yokohama City University Medical Center
Division name
Gynecology
Zip code
2320024
Address
4-57 Urafunecho, Minami-ku, Yokohama city
TEL
0452615656
saito_s@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | SHIN |
| Middle name | |
| Last name | SAITO |
Organization
Yokohama City University Medical Center
Division name
Gynecology
Zip code
2320024
Address
4-57 Urafunecho, Minami-ku, Yokohama city
TEL
0452615656
Homepage URL
saito_s@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city University
Institute
Department
Personal name
Funding Source
Organization
Fuji Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama city University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city
Tel
0457872800
rinri@yokohama-cu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preinitiation
Management information
Registered date
| 2025 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068236
