Clinical trial NCT01452659: Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids
Official title: A Phase II, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of TAK-385 10, 20, and 40 mg (p.o.) in the Treatment of Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uterine Fibroids
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-10-17
Enrollment: 216
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with uterine fibroids.

Detailed description: This study is a Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled for evaluation of the efficacy and safety of TAK-385 10, 20, and 40 mg (p.o.) following once daily administration for 12 weeks in women with uterine fibroids.

Eligibility criteria: Inclusion Criteria:

1. The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma.
2. The participant is a premenopausal woman.
3. The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography.
4. The participant has experienced regular menstrual cycles
5. The participant is diagnosed as menorrhagia

Exclusion Criteria:

1. Participants with a screening Hb \<8 g/dL
2. Participants with a previous or current history of blood disorders
3. Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods
4. Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
5. Participants with a previous or current history of thyroid dysfunction
6. Participants with a previous or current history of pelvic inflammatory disease
7. Participants with a positive PAP smear test result
8. Participants with a history of panhysterectomy or bilateral oophorectomy
9. Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
10. Participants with a previous or current history of a malignant tumor
11. Participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (SERM), activated vitamin D, other vitamin D, calcitonin, ipriflavone, steroid hormone, vitamin K, teriparatide, or denosumab
12. Participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (GnRH) analogue, dienogest, danazol, or aromatase inhibitor
13. Participants who have been treated with a bisphosphonate preparation
14. Participants with a previous or current history of severe hypersensitivity or severe allergy to drugs
15. Participants with non-diagnosable abnormal genital bleeding
16. Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
17. Participants with clinically significant cardiovascular disease or uncontrollable hypertension
18. Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
19. Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \> 1.5 times the upper limit of normal (ULN)

Primary outcomes:
measure: Decrease in menstrual blood loss
timeFrame: Week 12 (one menstrual cycle)
Secondary outcomes:
measure: Decrease in menstrual blood loss
timeFrame: Up to Week 6
measure: Decrease in menstrual blood loss
timeFrame: Up to Week 12.
measure: Amenorrhea
timeFrame: Week 12 (one menstrual cycle).
measure: Amenorrhea
timeFrame: Up to Week 6.
measure: Amenorrhea
timeFrame: Up to Week 12.
measure: Change in menstrual blood loss
timeFrame: Week 12 (one menstrual cycle)
measure: Myoma Volume
timeFrame: Up to Week 12.
measure: Uterine Volume
timeFrame: Up to Week 12.
measure: Hemoglobin Concentration in Blood
timeFrame: Up to Week 12.
measure: Pain Symptom
timeFrame: Up to Week 12.
measure: Other Clinical Symptoms
timeFrame: Up to Week 12.
measure: Quality of Life (QOL) Score
timeFrame: Up to Week 12.
measure: Bone Mineral Density
timeFrame: Up to Week 12.
measure: Treatment-emergent Adverse Events
timeFrame: Up to Week 16.
measure: Vital Signs
timeFrame: Up to Week 12.
measure: Body Weight
timeFrame: Up to Week 12.
measure: Electrocardiograms
measure: Laboratory Values
timeFrame: Up to Week 12
measure: Serum NTx
timeFrame: Up to Week 12
measure: Serum BAP
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Chiba-shi
country: Japan
state: Chiba
city: Itchihara-shi
country: Japan
state: Chiba
city: Matsuno-shi
country: Japan
state: Chiba
city: Matsuyama-shi
country: Japan
state: Ehime
city: Nihama-shi
country: Japan
state: Ehime
city: Fukui-shi
country: Japan
state: Fukui
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Iizuka-shi
country: Japan
state: Fukuoka
city: Yanagigawa-shi
country: Japan
state: Fukuoka
city: Mebashi-shi
country: Japan
state: Gunma
city: Ebetsu-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Amagasaki-shi
country: Japan
state: Hyogo
city: Kobe-shi
country: Japan
state: Hyogo
city: Kamakura-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Oita-shi
country: Japan
state: Oita
city: Ibaraki-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Sakai-shi
country: Japan
state: Osaka
city: Tondabayashi-shi
country: Japan
state: Osaka
city: Chuo-ku
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Suginami-ku
country: Japan
state: Tokyo
city: Toyama-shi
country: Japan
state: Toyama
Study officials:
affiliation: Takeda
name: Senior Director
role: STUDY_DIRECTOR
References:
citation: Hoshiai H, Seki Y, Kusumoto T, Kudou K, Tanimoto M. Relugolix for oral treatment of uterine leiomyomas: a dose-finding, randomized, controlled trial. BMC Womens Health. 2021 Oct 28;21(1):375. doi: 10.1186/s12905-021-01475-2.