UMIN-CTR Clinical Trial

Public title

A Randomized Parallel Group Controlled Study between
3.75 mg of Leuprorelin and 1.8 mg of Goserelin Depot in the Sequential Therapy (GnRH Agonist + Dienogest) for Treatment of Endometriosis

Acronym

A Randomized Parallel Group Controlled Study between
3.75 mg of Leuprorelin and 1.8 mg of Goserelin Depot in the Sequential Therapy (GnRH Agonist + Dienogest) for Treatment of Endometriosis

Scientific Title

A Randomized Parallel Group Controlled Study between
3.75 mg of Leuprorelin and 1.8 mg of Goserelin Depot in the Sequential Therapy (GnRH Agonist + Dienogest) for Treatment of Endometriosis

Scientific Title:Acronym

A Randomized Parallel Group Controlled Study between
3.75 mg of Leuprorelin and 1.8 mg of Goserelin Depot in the Sequential Therapy (GnRH Agonist + Dienogest) for Treatment of Endometriosis

Region

Japan

Condition

endometriosis, chocolate cyst or adenomyosis uteri

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Endometriosis, chocolate cyst and adenomyosis uteri are the diseases recurring repeatedly, and long-term therapeutic plan is required for treatment. In this study, the efficacy and safety of sequential therapy with GnRH agonist shall be compared for the purpose of long-term treatment in the female patients weighing 50 kg or more, who were diagnosed as endometriosis, chocolate cyst and adenomyosis uteri, and the efficacy and safety shall be compared among GnRH agonists.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Incidence of genital bleeding in 12 to 36 weeks after start of study (0 to 24 weeks after administration of dienogest)

Key secondary outcomes

The changes in the following items before and after treatment should be compared among 3 groups:
1. Improvement rate of subjective symptoms according to the VAS score
2. Reduction rate of the thickness of endometrium determined by the transvaginal ultrasonography before, 12 and 36 weeks after treatment
3. Reduction rate of the diameter of ovarian chocolate cyst determined by the transvaginal ultrasonography before, 12 and 36 weeks after treatment
4. Hormone kinetics, CA125 and other laboratory test values
5. Bone density and bone metabolism marker
6. Incidence of adverse reaction and discontinuation rate

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Numbered container method

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1. Leuprorelin + dienogest treatment group (Group L):
Leuprorelin acetate should be administered subcutaneously once 4 weeks (28 days) at a dose of 3.75 mg for 12 weeks (initial administration should be performed during menstruation), and dienogest should be administered orally at a daily dose of 2 mg in two divided doses for 24 weeks without establishing the withdrawal period. (Total period of administration: 36 weeks)

Interventions/Control_2

2. Goserelin + dienogest treatment group (Group G):
Goserelin acetate should be administered subcutaneously once 4 weeks (28 days) at a dose of 1.8 mg for 12 weeks (initial administration should be performed during menstruation), and dienogest should be administered orally at a daily dose of 2 mg in two divided dose for 24 weeks without establishing the withdrawal period. (Total period of administration: 36 weeks)

Interventions/Control_3

3. Dienogest treatment group (Group D):
Dienogest should be administered orally at a daily dose of 2 mg in two divided doses for 36 weeks (initial administration should be performed during menstruation).

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1. Patients aged 20 years or older and weighing 50 kg or more at acquisition of consent
2. Patients diagnosed as endometriosis, chocolate cyst or adenomyosis uteri
3. Patients with ovulatory menstruation
4. Patients who received sufficient explanation before participation in this study, understood it and gave written consent based on the free will of the patient oneself

Key exclusion criteria

1. Patients with undiagnosed abnormal genital bleeding
2. Pregnant or possibly pregnant women
3. Lactating patients
4. Patients with a past history of hypersensitivity to GnRH agonists or dienogest
5. Patients treated with hormone drugs (oral contraceptive, danazol, GnRH agonists, etc.) and dienogest within the past 4 months
6. Other patients considered ineligible as subjects by investigator

Target sample size

120

Name of lead principal investigator

1st name
Middle name
Last name	Hideo Matsui

Organization

Tokyo Women's Medical University

Division name

Department of Obstetrics and Gynecology

Zip code

Address

8-1Kawada-cho,Shinjuku-ku,Tokyo,JAPAN

TEL

03-3353-8111

Email

Name of contact person

1st name
Middle name
Last name	Kazunori Hashimoto

Organization

Tokyo Women's Medical University

Division name

Department of Obstetrics and Gynecology

Zip code

Address

8-1Kawada-cho,Shinjuku-ku,Tokyo,JAPAN

TEL

03-3353-8111

Homepage URL

Email

kahashi@obgy.twmu.ac.jp

Institute

Tokyo Women's Medical University
Department of Obstetrics and Gynecology

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京女子医科大学（東京都）

Date of disclosure of the study information

2013

Year

03

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2012

Year

06

Month

22

Day

Date of IRB

Anticipated trial start date

2013

Year

03

Month

28

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

03

Month

27

Day

Last modified on

2013

Year

03

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012093