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

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 - 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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010332

Enrollment

120

Registered

2013-03-28

Start date

2013-03-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometriosis, chocolate cyst or adenomyosis uteri

Interventions

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 shoul

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Japan

Contacts

Public ContactKazunori Hashimoto

Tokyo Women's Medical University Department of Obstetrics and Gynecology

kahashi@obgy.twmu.ac.jp03-3353-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026