Clinical trial NCT01458301: Efficacy and Safety of TAK-385 in the Treatment of Endometriosis
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 Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 487
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 endometriosis.

Detailed description: This Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled study will evaluate the efficacy and safety of 3 dose levels (10, 20, and 40 mg) of TAK-385 following oral administration for 12 weeks in women with endometriosis.

Eligibility criteria: Inclusion Criteria:

1. Premenopausal women
2. The participants must have dysmenorrhea and pelvic pain associated with endometriosis.
3. The participant has experienced a regular menstrual cycle.
4. The participant has been diagnosed with endometriosis by method a), b), or c).

   * Laparotomy
   * Laparoscopy
   * Chocolate cyst of the ovary confirmed by MRI

Exclusion Criteria:

1. Participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger
2. Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
3. Participants with a previous or current history of thyroid dysfunction
4. Participants with current or previous history of pelvic inflammatory disease
5. Participants with positive PAP smear test result conducted
6. Participants with a history of panhysterectomy or bilateral oophorectomy
7. Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
8. Participants with a previous or current history of a malignant tumor
9. 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
10. 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
11. Participants who have been treated with bisphosphonate preparation
12. Participants with a previous or current history of hypersensitivity or allergy to Leuplin, synthetic LH-RH, LH-RH derivatives, gelatin-containing formulations or food containing gelatin, or have a previous or current history of severe hypersensitivity or severe allergy to other drugs
13. Participants with non-diagnosable abnormal genital bleeding
14. Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
15. Participants with clinically significant cardiovascular disease or uncontrollable hypertension
16. Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
17. 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) in the clinical laboratory tests

Primary outcomes:
measure: Score for pelvic pain as measured by the Visual Analogue Scale (VAS)
timeFrame: Week 12 (one menstrual cycle)
Secondary outcomes:
measure: VAS Score for Pelvic Pain
timeFrame: Up to Week 12.
measure: VAS Score for Dyspareunia
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.
timeFrame: Up to Week 12.
measure: Number of Participants with Markedly Abnormal Standard Safety Laboratory Values
timeFrame: Up to Week 24
measure: Serum NTx
timeFrame: Up to Week 12.
measure: Serum BAP
timeFrame: Up to Week 12.
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
state: Aichi
city: Chiba-shi
country: Japan
state: Chiba
city: Funabashi-shi
country: Japan
state: Chiba
city: Ichihara-shi
country: Japan
state: Chiba
city: Yachiyo-shi
country: Japan
state: Chiba
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: Kitakyushu-shi
country: Japan
state: Fukuoka
city: Onga-gun
country: Japan
state: Fukuoka
city: Yanagawa-shi
country: Japan
state: Fukuoka
city: Koriyama-shi
country: Japan
state: Fukushima
city: Takayama-shi
country: Japan
state: Gifu
city: Takasaki-shi
country: Japan
state: Gunma
city: Hirosima-shi
country: Japan
state: Hirosima
city: Ebetsu-shi
country: Japan
state: Hokkaido
city: Ishikari-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Amagasaki-shi
country: Japan
state: Hyogo
city: Kako-gun
country: Japan
state: Hyogo
city: Kawanishi-shi
country: Japan
state: Hyogo
city: Kobe-shi
country: Japan
state: Hyogo
city: Kanazawa-shi
country: Japan
state: Ishikawa
city: Marugame-shi
country: Japan
state: Kagawa
city: Kagoshima-shi
country: Japan
state: Kagoshima
city: Hiratsuka-shi
country: Japan
state: Kanagawa
city: Kamakura-shi
country: Japan
state: Kanagawa
city: Kawasaki-shi
country: Japan
state: Kanagawa
city: Yamato-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Nankoku-shi
country: Japan
state: Kochi
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Kyoto-shi
country: Japan
state: Kyoto
city: Sendai-shi
country: Japan
state: Miyagi
city: Matsumoto-shi
country: Japan
state: Nagano
city: Nagano-shi
country: Japan
state: Nagano
city: Suzaka-shi
country: Japan
state: Nagano
city: Nara-shi
country: Japan
state: Nara
city: Oita-shi
country: Japan
state: Oita
city: Kurashiki-shi
country: Japan
state: Okayama
city: Okayama-shi
country: Japan
state: Okayama
city: Hirakata-shi
country: Japan
state: Osaka
city: Ibaraki-shi
country: Japan
state: Osaka
city: Ikeda-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Sakai-shi
country: Japan
state: Osaka
city: Suita-shi
country: Japan
state: Osaka
city: Tondabayashi-shi
country: Japan
state: Osaka
city: Toyonaka-shi
country: Japan
state: Osaka
city: Iruma-shi
country: Japan
state: Saitama
city: Kusatsu-shi
country: Japan
state: Shiga
city: Hamamatsu-shi
country: Japan
state: Shizuoka
city: Numazu-shi
country: Japan
state: Shizuoka
city: Yaizu-shi
country: Japan
state: Shizuoka
city: Komatsushima-shi
country: Japan
state: Tokushima
city: Naruto-shi
country: Japan
state: Tokushima
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Machida-shi
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Ohta-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
city: Yamaguchi-shi
country: Japan
state: Yamaguchi
Study officials:
affiliation: Takeda
name: Senior Director
role: STUDY_DIRECTOR
References:
citation: Osuga Y, Seki Y, Tanimoto M, Kusumoto T, Kudou K, Terakawa N. Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study. Fertil Steril. 2021 Feb;115(2):397-405. doi: 10.1016/j.fertnstert.2020.07.055. Epub 2020 Sep 7.