An open-label investigation into the tolerability and pharmacokinetic / pharmacodynamic effects of sufugolix (TAK-013), at a dosage of 100mg twice-daily, during six months treatment of pre-menopausal women with endometriosis.

• Conditions: symptomatic endometriosis; MedDRA version: 7Level: LLTClassification code 10014778

• Registration Number: EUCTR2004-003829-28-DE
• Lead Sponsor: Takeda Europe R&D Centre Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 20

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.

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified