UMIN-CTR Clinical Trial

Basic information
Public title	The Influence on SPecific Activity of protein S and coagulation system : Dienogest and low dose estrogen-progestin for Endometriosis.
Acronym	The Influence on SPecific Activity of protein S and coagulation system : Dienogest and low dose estrogen-progestin for Endometriosis. (SPADE)
Scientific Title	The Influence on SPecific Activity of protein S and coagulation system : Dienogest and low dose estrogen-progestin for Endometriosis.
Scientific Title:Acronym	The Influence on SPecific Activity of protein S and coagulation system : Dienogest and low dose estrogen-progestin for Endometriosis. (SPADE)
Region	Japan

Condition
Condition	Endometriosis
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify an influence of dienogest and low dose estrogen-progestin for endometriosis on protein S- specific activity.
Basic objectives2	Others
Basic objectives -Others	Change of protein S-specific activity (total activity, total antigen level and those ratios)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of protein S specific activity (total activity, total antigen level and those ratios)
Key secondary outcomes	Effect of dienogest and low dose estrogen-progestin on the parameters of coagulation system (excluding protein S specific activity), incidence of venous thromboembolism, incidence ratios of adverse event (including the abnormal change of laboratory test to be clinically problem).

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	Prevention
Type of intervention	Other
Interventions/Control_1	The laboratory tests are carried out at 4 times before and during treatment period.
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	50 years-old >
Gender	Female
Key inclusion criteria	1. Patients with treatment start plan of dienogest or low dose estrogen-progestin for endometriosis. 2. Female patients with more than 20 years and less than 50 years at the date of informed consent. 3. Patients with menstrual cycle. 4. Patients providing the written informed consent.
Key exclusion criteria	1. Patients with pregnant or the possibility of pregnancy. 2. Patients with post partum within 4 weeks or with lactation. 3. Patients with abnormal genital bleeding not to be diagnosed. 4. Patients with the complication of malignant tumor or the suspicion of complication. 5. Patients with severe hepatic disorder or hepatic tumor. 6. Patients within 4 weeks after the operation (excluding operational duration of less than 30 min). 7. Patients without continuous administration for 24 weeks. 8. Patients with treatment history of steroidal hormones including sex hormones and GnRH agonist within the past 3 months. 9. Patients under anticoagulation and antiplatelet drug. 10. Patients with hypersensitivity to the constituents of the study drug (dienogest tablets or low dose estrogen-progestin tablets). 11. Patients with contraindication of Lunabell tablet LD/ULD and Yaz tablet in low dose estrogen-progestin group. 12. Patient who is judged to be inappropriate for study participation for any reason by the doctor.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kiyoko Kato
Organization	Kyushu University Hospital
Division name	Department of Obstetrics and Gynecology
Zip code
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka
TEL	092-642-5395
Email	kkato@med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Natsuko Yokota
Organization	Kyushu University Hospital
Division name	Department of Obstetrics and Gynecology
Zip code
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka
TEL	092-642-5395
Homepage URL
Email	natsuko.yokota.192@s.kyushu-u.ac.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, Kyushu University Hospital
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Other
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	九州大学病院（福岡県）、長崎国際大学（長崎県）、国家公務員共済組合連合会 浜の町病院（福岡県）、医療法人　親愛ステーションクリニック（福岡県）、医療法人 中央レディスクリニック（福岡県）、北九州市立医療センター（福岡県）、独立行政法人地域医療機能推進機構JCHO九州病院（福岡県）、済生会支部福岡県　済生会福岡総合病院（福岡県）、日本赤十字社　福岡赤十字病院（福岡県）、医療法人社団　高邦会　福岡山王病院（福岡県）、医療法人社団　水光会　宗像水光会総合病院（福岡県）、国立病院機構福岡東医療センター（福岡県）、順天堂大学医学部附属順天堂医院（東京都）、公益財団法人東京都保険医療公社　東部地域病院（東京都）、越谷市立病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 10 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	2016 Year 05 Month 12 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 08 Month 27 Day
Date analysis concluded	2019 Year 12 Month 23 Day

Other
Other related information	Prospective cohort study Dienogest group and low dose estrogen-progestin group patients who take hormonal treatment for endometriosis from May X,2016 to September 30,2017 and meet inclusion criteria. Clinical examination Protein S-specific activity,Protein S activity,Protein C activity,PT,APTT,D-dimer,fibrinogen,Thrombin-antithrombin complex,estradiol,progesteron

Management information
Registered date	2016 Year 05 Month 10 Day
Last modified on	2020 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025653