A study comparing Relugolix to Leuprorelin acetate for treatment of adenomyosis with dysmenorrhea

JRCT ID: jRCTs041240085

Registered date:12/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Adenomyosis
• Date of first enrollment: 12/09/2024
• Target sample size: 46
• Study type: Interventional

Intervention(s)

Relugolix
Oral administration of 40 mg of Relugolix once daily before meals for 12 weeks.

Leuprorelin Acetate
Subcutaneous administration of 1.88 mg of leuprorelin acetate once every 4 weeks, for a total of 4 times.

Outcome(s)

• Primary Outcome: Change from baseline in the total dysmenorrhea score after 12 weeks of administration

Secondary Outcome

Change from baseline total dysmenorrhea score after 4 and 8 weeks of administration
Change from baseline on dysmenorrhea severity scores after 4, 8, and 12 weeks of administration
Change from baseline in analgesic use scores after 4, 8, and 12 weeks of administration
Change from baseline in VAS for dysmenorrhea after 4, 8, and 12 weeks of administration
Change from baseline in non-menstrual VAS (pelvic pain) after 4, 8, and 12 weeks of administration
Change from baseline in number of days with nonmenstrual pelvic pain after 4, 8, and 12 weeks of administration
Change from baseline in uterine volume after 12 weeks of administration
Change from baseline maximum myometrial thickness after 12 weeks of administration
Change from baseline in blood hormone levels after 12 weeks of administration
Incidence of hot flashes and sweating after 4, 8, and 12 weeks of administration
Change from baseline in menopausal scores after 4, 8, and 12 weeks of administration
Incidence of irregular uterine bleeding after 4, 8, and 12 weeks of treatment
Adverse events, or diseases

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1 Premenopausal patients who are at least 18 years old at the time of informed consent.
2 Patients with a total dysmenorrhea score of 3 or more in the last menstrual cycle before enrollment.
3 Patients diagnosed with adenomyosis using MRI during the screening period. In addition, it is also possible to use MRI results from within 12 weeks before obtaining consent as the basis for a diagnosis.
4 Patients who make entries in their patient diary in the screening period.
5 Patients who provide written informed consent.

Exclude criteria

1 Patients with a BMI greater than 30 at the time of informed consent.
2 Patients diagnosed with ovarian endometrioma during an MRI diagnosis of adenomyosis during screening.
3 Patients with undiagnosed abnormal vaginal bleeding or endometrial hyperplasia.
4 Patients with uterine submucous myoma
5 Patients determined by the principal investigator or co-investigators to have abdominal distention attributable to an enlarged uterus.
6 Patients who have been taking analgesics almost every day prior to the study period for therapeutic purposes other than relief of pelvic pain from dysmenorrhea (lower abdominal pain and back pain), and who may continue to use them regularly during the study period (occasional use is allowed).
* "Occasional use" means taking analgesics as needed according to symptoms, rather than regularly.
7 Patients who have received relugolix or leuprorelin acetate.
8 Patients who received the following drugs within 4 weeks before obtaining informed consent.
Gn-RH analogs, testosterone derivatives
Hormone agents containing progesterone or estrogen as the main ingredient
estrogen antagonists, aromatase inhibitors
9 Patients who received other investigational drugs/experimental drugs within 12 weeks prior to obtaining consent.
10 Patients scheduled for surgical treatment for adenomyosis during the study period.
11 Patients with findings of concomitant or suspected malignancy.
12 Patients with concomitant or history of depression.
13 Patients unable to undergo MRI imaging under the conditions specified in this study.
14 Pregnant women, nursing mothers, or patients who may be pregnant.
15 Other patients who are judged by the principal investigator/co-investigators to be ineligible for enrollment in this clinical trial.

Related Information

• Primary Sponsor: Kikuno Kyoko