SPIRIT 2
Research type
Research Study
Full title
SPIRIT 2: An International Phase 3 Randomized, Double- Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain
IRAS ID
229043
Contact name
Nicholas Raine-Fenning
Contact email
Sponsor organisation
Myovant Sciences, GmbH
Eudract number
2017-001632-19
Clinicaltrials.gov Identifier
076642, IND Number
Duration of Study in the UK
1 years, 6 months, 10 days
Research summary
Endometriosis is a common chronic condition, occurring in women of reproductive age, where tissue that behaves like the lining of the womb (endometrium) is found in other parts of the body such as the ovaries and fallopian tubes. Each month, these cells react in the same way to those in the womb, building up and breaking down and bleeding. This can lead to chronic pain and infertility. Around 1.5 million women in the UK are living with this condition. Nearly half of those affected experience chronic pelvic pain. Currently, there is no way of preventing endometriosis.
Relugolix is being developed as a treatment of endometriosis-associated pain. Relugolix blocks certain receptors in the pituitary gland (a pea-sized gland, located in the brain, involved in hormone control) leading to suppression of oestradiol (a female sex hormone which is essential for reproductive tissue and bone development/maintenance).
Up to 600 female patients, aged between 18-50 years old, will be recruited to this study at approximately 160 sites globally. Eligible participants will be randomised equally to 1 of 3 groups. The first group will receive a daily 40 mg tablet of relugolix plus a daily capsule of low-dose oestradiol and norethindrone (a combination medicine used to treat menopause symptoms and to prevent bone loss) for 24 weeks. The second group will receive a daily 40 mg relugolix tablet plus a daily placebo capsule for 12 weeks followed by daily 40 mg relugolix tablet plus a daily low-dose oestradiol and norethindrone capsule for the next 12 weeks. The final group will receive a daily placebo tablet and capsule for 24 weeks.
Participants will undergo various tests and procedures including blood samples, urine samples, electrocardiograms, physical examinations and eDiary/questionnaire completion.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0355
Date of REC Opinion
14 Nov 2017
REC opinion
Further Information Favourable Opinion