A Phase III, multi-center, randomized, double-blind comparator study to evaluate the efficacy and safety of 50 mg and 100 mg of TAK-013 tablets administered twice daily versus 3.75mg of Leuprolide administered monthly for 24 weeks in subjects with symptomatic endometriosis.
- Conditions
- EndometriosisMedDRA version: 7Level: LLTClassification code 10014778
- Registration Number
- EUCTR2004-001720-21-GB
- Lead Sponsor
- Takeda Europe R&D Centre Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 200
1.The subject is a pre-menopausal female and must be 18 to 45 years of age, inclusive.
2.Female subjects of childbearing potential must be non-pregnant and non-lactating. In addition to a negative human chorionic gonadotropin (HCG) pregnancy test at Screening, they must also have a negative urine HCG pregnancy test result on the day of randomization (Day 0), prior to receiving any dose of study medication.
From screening until Visit 12, subjects of child bearing potential (e.g. non-sterilized) who are sexually active, must use adequate contraception, unless the sexual partner has undergone vasectomy with proven azoospermia. All subjects will be asked to confirm that they understand the requirements for avoidance of pregnancy during the course of the study as part of the informed consent process. During the course of the study females of child-bearing potential will receive continued advice on avoidance of pregnancies as part of the study procedures.
The acceptable method for this study is double-barrier contraception. Accepted barrier contraceptive devices include; male condom, female condom, diaphragm, and cap. Double barrier contraception is defined as two different barrier devices used simultaneously, each time the subject has intercourse.
Note: contraception methods, which are not accepted include: oral contraceptive pills, natural rhythm” methods, withdrawal and spermicides (used alone).
3.Endometriosis diagnosis has been laparoscopically or laparotomy confirmed, or has been re-confirmed in the last 3 years prior to study screening.
4.The subject has symptomatic endometrosis within 1 month prior to screening. A subject is considered to be symptomatic if BOTH of the dysmenorrhea and pelvic pain symptoms are present, one of which is at least moderate, as described in the Biberoglu and Behrman Pain Grading Scale, see Table 2.
5.The subject must have normal menses for at least 2 cycles prior to screening and a cycle duration of 21-35 days.
6.If the subject has had surgical reduction of their endometriosis, they must have recurrence of dysmenorrhea and pelvic pain for at least 3 months post-surgery, which in the investigator’s opinion is due to their endometriosis.
7.With the exception of endometriosis, the subject is otherwise in good health, with no clinically relevant hepatic, renal, cardiovascular, endocrine, metabolic, psychiatric, neurologic, hematologic disease, or any other significant illness or clinical condition.
8.The subject is able and willing to undertake all study-required procedures and has the ability to take oral medications.
9.The subject has given written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.The subject has clinically significant cardiovascular disease that would preclude them from participating in the study (e.g., myocardial infarction or unstable angina).
2.The subject has a history of any form of cancer (other than adequately treated basal cell and squamous cell cancers of the skin).
3.The subject has been treated with the following medications within 3 months prior to the administration of the first dose of study medication: Depo-Provera; medications significantly affecting bone metabolism such as raloxifene, calcitonin and bisphosphonates. The investigator should consider any history of prior GnRH analogue therapy with respect to possible bone mineral density loss to assess subject suitability for entry into the study.
4.The subject has been treated with the following medications within 3 months prior to Screening: oral contraceptives; sex hormone medications such as norethindrone or estrogen preparations and Danazol.
5.The subject has a positive pregnancy test.
6.The subject is less than 3 months postpartum or post-lactation at the time of the first dose of study medication.
7.The subject has a known hypersensitivity to sufugolix (TAK-013) or Leuprolide.
8.The subject has abnormal menstrual bleeding unrelated to endometriosis.
9.The subject has a body mass index (BMI) > 40 kg/m2.
10.The subject has a known history of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as routine consumption of more than 4 alcoholic drinks per day) within the past 2 years prior to study entry.
11.The subject is currently participating in any clinical trial (marketed product or otherwise) or has done so within 30 days prior to the screening visit.
12.The subject is known to be HIV positive, Hepatitis B surface antigen (HBsAg) or Hepatitis C (HCV) positive.
13.The subject has a known ALT/SGPT and/or AST/SGOT of >1.5 times ULN, a known bilirubin >1.5 mg/dL, or has any hepatic or renal impairment.
14.The subject has any disease or disease state that in the opinion of the investigator would interfere with the study (e.g., chronic depression that requires treatment).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method