E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
symptomatic endometriosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014778 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To establish, through diary recordings of vaginal bleeding, the frequency of patients achieving suppression of menses during the treatment period from Week 8 (inclusive) to Week 24 (end of the treatment with study medication). |
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E.2.2 | Secondary objectives of the trial |
To characterise treatment-related changes in serum E2 levels within the study population during the 24-week study treatment and 4-week follow-up periods.
To characterise the pharmacokinetics of sufugolix (TAK-013) during the 24-week treatment period - assessed by serial (trough) plasma concentrations of the parent compound within the study population.
To evaluate the safety profile of sufugolix (TAK-013) over the study duration. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Pre-menopausal females aged between 18 and 45 years inclusive.
2. New diagnosis of symptomatic endometriosis, or recorded confirmation / re-confirmation by laparoscopy within the 3 years prior to study enrolment. Subjects should have one or more current symptoms comprising dysmenorrhea, pelvic pain, dyspareunia.
3. Body Mass Index (BMI) <40 kg/m2.
4. Normal menses - defined as three or more consecutive days of bleeding which requires protection, and a cycle duration of 21 - 35 days for at least two menstrual cycles prior to study screening.
5. Neither pregnant nor lactating - with negative urine pregnancy tests at study screening and at enrolment (prior to receiving the first dose of study medication).
6. Acceptable method of contraception during the entire study duration - defined as use of either a condom plus spermicide preparation, condom plus cap (with or without spermicide) or diaphragm plus condom (with or without spermicide);
[Note Unacceptable contraception methods include: oral contraceptive pills or other hormonal methods, IUDs, natural “rhythm” methods, withdrawal and spermicides, condoms, caps or diaphragms used alone.]
7. With the exception of endometriosis, the subject should otherwise be in good health, with no clinically relevant hepatic, renal, cardiovascular, endocrine, metabolic, psychiatric, neurological, hematological disease, or any other significant illness or clinical condition.
8. Ability to comprehend, and willingness to sign, an Informed Consent Form.
9. Ability and willingness to undertake all study-related procedures - including the taking of oral medication.
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E.4 | Principal exclusion criteria |
1. History of any form of cancer (other than adequately treated basal cell and squamous cell cancers of the skin).
2. Known to be HIV positive, Hepatitis B surface antigen (HBsAg) or Hepatitis C (HCV) positive.
3. ALT/SGPT >1.5 times ULN, bilirubin >1.5 mg/dL, any hepatic or renal impairment.
4. Hysterectomy and/or bilateral oophorectomy.
5. Abnormal menstrual bleeding unrelated to endometriosis.
6. History of osteoporosis, osteopenia, hypocalcemia or other metabolic bone disease.
7. Known or documented history of severe allergic or idiosyncratic reactions to any drug – including sufugolix (TAK-013).
8. Known history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within the 2 years prior to study enrolment.
9. Use of the following medications in the 3 months prior to study enrolment and throughout the study: GnRH analogues, oral contraceptives, sex hormone medications (including - but not limited to - norethindrone or norethindrone acetate, depomedroxyprogesterone, estrogen preparations, other progestins) and Danazol. Investigators should consider any history or prior use of GnRH analogue therapy in terms of possible bone mineral density loss, and take account of such effects in establishing suitability of subjects for this study. (section 7.10 also lists other concomitant medications prohibited throughout the course of this study.)
10. A positive pregnancy test.
11. Less than 3 months post-partum or post-lactation at onset of therapy within this study.
12. Surgery (other than laparoscopy for endometriosis) planned to occur during the 8 months which follow study screening.
13. Current participation in any clinical trial (marketed product or otherwise) or within the 30 days prior to the study screening.
14. Any disease or disease state that, in the opinion of an investigator, would interfere with the study (e.g. chronic depression requiring treatment).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint for efficacy will be the frequency of subjects for whom suppression of menses is achieved during the study treatment period from Week 8 (inclusive) to Week 24 (end of the treatment with study medication). The data will be derived from daily vaginal bleeding scores recorded in diaries by the study patients throughout the treatment period. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |