UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057362 |
|---|---|
| Receipt number | R000064473 |
| Scientific Title | Efficacy of estetrol/drospirenone combination drug in premenstrual syndrome/premenstrual dysphoric disorder, an open-label,multicenter, prospective observational study |
| Date of disclosure of the study information | 2025/03/22 |
| Last modified on | 2026/03/23 13:44:16 |
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Basic information
Public title
Efficacy of estetrol/drospirenone in premenstrual syndrome/premenstrual dysphoric disorder
Acronym
Effectiveness of E4/DRSP for PMS/PMDD
Scientific Title
Efficacy of estetrol/drospirenone combination drug in premenstrual syndrome/premenstrual dysphoric disorder, an open-label,multicenter, prospective observational study
Scientific Title:Acronym
Efficacy of E4/DRSP for PMS/PMDD, a prospective open-label study
Region
| Japan |
Condition
Condition
Premenstrual syndrome, Premenstrual dysphoric disorder
Classification by specialty
| Psychosomatic Internal Medicine | Obstetrics and Gynecology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective of this study is to verify the efficacy of low dose estrogen-progestin containing E4 and DRSP for PMS/PMDD by analyzing the results of questionnaires completed by the participants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of total MDQ scores and sub-scores at the start of treatment with E4/DRSP combination treatment after 6 cycles.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1. Women 18 years of age or older at the time of registration.
2. Patients who visited an obstetrics and gynecology clinic for the treatment of dysmenorrhea and chose to be treated with E4/DRSP combination tablets.
3. Patients who reported some premenstrual symptoms and were diagnosed with moderate or severe PMS or PMDD using the Premenstrual Symptom Screening Tool (PSST).
4. Patients with regular menstrual cycles
5. Patients who provided written informed consent to participate in the study.
Key exclusion criteria
1. Patients who have used oral contraceptives or hormonal agents containing progestins for the treatment of dysmenorrhea within 3 months prior to study entry.
2. Patients with any of the contraindications for use of E4/DRSP combination products.
3. Patients already being treated for PMS/PMDD
4. Patients who are pregnant, breastfeeding, or planning to become pregnant during the study.
5. Patients who were unable to continue attending the clinic and taking E4/DRSP until the fifth visit.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Ogawa |
Organization
Fukushima Medical University
Division name
Fukushima Medical Center for Children and Women
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Fukushima
TEL
024-547-1111
ogawam@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Ogawa |
Organization
Fukushima Medical University
Division name
Fukushima Medical Center for Children and Women
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Fukushima
TEL
024-547-1111
Homepage URL
ogawam@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Mariko Ogawa
Funding Source
Organization
Fuji Pharma Co., Ltd.
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
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, Fukushima
Tel
024-547-1111
rs@fmu.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 | 03 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2025 | Year | 03 | Month | 22 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064473
