UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020865 |
|---|---|
| Receipt number | R000023963 |
| Scientific Title | Comparison of postoperative administration between dienogest and ultra low dose estrogen and progesterone tablet for suppressing recurrence of ovarian endometriomas: A randomized study |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2019/09/02 16:40:17 |
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Basic information
Public title
Comparison of postoperative administration between dienogest and ultra low dose estrogen and progesterone tablet for suppressing recurrence of ovarian endometriomas: A randomized study
Acronym
Comparison of postoperative administration between dienogest and ultra low dose estrogen and progesterone tablet for suppressing recurrence of ovarian endometriomas: A randomized study
Scientific Title
Comparison of postoperative administration between dienogest and ultra low dose estrogen and progesterone tablet for suppressing recurrence of ovarian endometriomas: A randomized study
Scientific Title:Acronym
Comparison of postoperative administration between dienogest and ultra low dose estrogen and progesterone tablet for suppressing recurrence of ovarian endometriomas: A randomized study
Region
| Japan |
Condition
Condition
endometriosis (ovarian endometrioma)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to test the efficacy and safety of dienogest and ultra low dose estrogen and progesterone tablet (LUNABELL tablets ULD) for suppressing recurrence of ovarian endometriomas after primary surgery. We sought to create clinical data and establish optimal treatment of postoperative ovarian endometriomas.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Primary outcome is the recurrence rate 2 years after surgery.
The definition of recurrence is the presence of endometriomas more than 2 cm by transvaginal ultrasound on at least two consecutive examinations.
Follow-up visits and transvaginal ultrasound are scheduled every 3 months after commencement of treatment.
Pelvic MRI is performed when recurrence is suspected.
Key secondary outcomes
The patients are asked to score the intensity of pelvic pain at the follow-up visit using a visual analogue scale (VAS) score. Disease recurrence is defined as sequential increase of VAS score or increase of VAS score as high as preoperative score.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dienogest
1mg twice a day (2mg/day)
From menstrual cycle day 2-5
For 24 months
Interventions/Control_2
ultra low dose estrogen and progesterone tablet
1 tablet once a day (at the same time of each day)
From menstrual cycle day 2-5
After taking tablets for 21 days, patients stop it for 7 days. These 28 days is one cycle. Whether withdrawal bleeding stops or not, patients start to take the tablet from cycle day 29. It is repeated thereafter for 24 months.
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
(a) Patients who had undergone laparoscopic surgery for ovarian endometriomas at Osaka University Hospital, Minoh City Hospital or Toyonaka Municipal Hospital
(b) Patients who consent to this study in writing
(c) Patients who do not want to become pregnant during this study period
(d) Patients more than 20 years old and not more than 50 years old
Key exclusion criteria
(a) undiagnosed genital bleeding
(b) pregnant, probably pregnant or lactating
(c) allergic to ingredient of dinagest tablets or LUNABELL tablets ULD
(d) patients who want to become pregnant
(e) estrogen dependent malignant tumor (e.g. breast cancer, endometrial cancer), cervical cancer or suspected to have those diseases
(f) thrombophlebitis, pulmonary embolism, cerebrovascular accident and coronary artery disease, or past history of those diseases
(g) more than 35 years old and smoke more than 15 cigarettes
(h) migraine with aura (e.g. fortification spectrum etc.)
(i) valvular disease with pulmonary; hypertension or atrial fibrillation valvular disease with past history of subacute infectious endocarditis
(j) diabetes with vascular disease (diabetic nephropathy, diabetic retinopathy etc.)
(k) primary cause of thrombosis
(l) antiphospholipid antibody syndrome
(m) within 4 weeks before surgery, within 2 weeks after surgery, within 4 weeks after delivery, or long-term bed rest
(n) severe liver damage
(o) liver tumor
(p) lipid metabolism abnormality
(q) hypertension (except mild hypertension)
(r) otosclerosis
(s) past history of jaundice, persistent pruritus or herpes during pregnancy
(t) probably in the middle of bone growth
(u) patients who are judged ineligible by doctor in charge for other reasons
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Kimura |
Organization
Osaka University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3351
tadashi@gyne.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mami Morikawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3354
Homepage URL
mami0204@gyne.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Minoh City Hospital
Toyonaka Municipal Hospital
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
大阪大学病院（大阪府）、箕面市立病院、市立豊中病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 03 | Day |
Last modified on
| 2019 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023963
