Phase I study investigating the effect of OBE2109 on sex hormones
Research type
Research Study
Full title
A randomized open-label clinical pharmacology study investigating the effect of OBE2109 and add-back therapy on estradiol pharmacokinetics.
IRAS ID
218656
Contact name
Anna Parzybut
Contact email
Sponsor organisation
ObsEva SA
Eudract number
2016-004732-38
Duration of Study in the UK
0 years, 3 months, 26 days
Research summary
This is a Phase 1 study in healthy female volunteers. A total of 75 females aged 18 to 48 will be enrolled. The study drug, OBE2109 is being developed for the treatment of endometriosis and uterine fibroids.\n\nThe study purpose is to assess how OBE2109 works within the body, and to study effects on estrogen, an ovarian hormone, both alone and in combination with marketed HRT. The study will also assess the effect of the study drug in combination with HRT on menstrual bleeding.\n\nThe study drug OBE2109 blocks the production of estradiol. Low estradiol levels are associated with endometriosis and uterine fibroids symptom relief, but excessive estradiol reduction may lead to side-effects. We may “add-back” in low levels of estradiol with another drug, HRT. \n\nScreening will take place over a 28-day period prior to a run-in period of 15 days. Each volunteer will be taking norethisterone 5mg tablets 3 times a day for 10 days in order to synchronise menstrual cycle prior to receiving study medication. Then each volunteer will be randomised to receive OBE2109 alone or with one of the HRT drugs according to one of the 5 treatment regimens.\nThere will be 15 outpatient visits, and a 2-night stay in the clinic.\n\nAt the outpatient visits each volunteer will be given the study medications and instructions for use. \n\nEach day they are self-administering they will receive a text message from the study team to remind them to take their medications and they will text back a response that they have complied.\n\nDuring the stay in the clinic volunteers will fast before taking their study medication and blood samples will be taken.\nA questionnaire to record menstrual bleeding pattern will be completed throughout the study.\n\nThe total study time will be up to 98 days including the screening.
REC name
HSC REC A
REC reference
16/NI/0261
Date of REC Opinion
20 Dec 2016
REC opinion
Further Information Favourable Opinion