T-814 in menopausal females with vasomotor symptoms (SWITCH-1 study)
- Conditions
- Hot flushes (vasomotor symptoms) in menopausal womenMedDRA version: 20.0Level: LLTClassification code 10027311Term: Menopause flushingSystem Organ Class: 100000004872Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2018-002763-26-GB
- Lead Sponsor
- eRRe Therapeutics Ltd,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 165
1.Females aged 40 to 65 years, inclusive, at Screening Visit 1
2.Able to understand and comply with the requirements of the study and give informed consent
3.Postmenopausal, defined as: (i) at least 12 months of spontaneous amenorrhea, or (ii) at least 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml and a serum oestradiol concentration of < 30 pg/mL, or (iii) at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
4.Body mass index between 18 and 38 kg/m2, inclusive, at Screening Visit 2
5.Negative urinary pregnancy test at Screening Visit 2
6.In good general health, in the opinion of the investigator, based on the medical history, physical examination, 12-lead ECG, vital signs and clinical laboratory tests assessed at Screening Visit 2
7.Subject has completed the paper diary for at least 6 days between Screening Visits 1 and 2 and has recorded an average of at least 8 moderate or severe hot flushes per day (including night-time) over the last 5 days that the paper diary was completed (assessed at Screening Visit 2)
8.Subject has completed the eDiary for at least 9 days between Screening Visit 2 and Day 1 and has recorded an average of at least 7 moderate or severe hot flushes per day (including night-time) over the last 7 days that the eDiary was completed (assessed at the Baseline Visit)
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 164
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
1.Have used or unwilling to wash-out use of any of the following hormonal therapies for the periods stated prior to Screening Visit 2:
->1 week for vaginal hormonal products (rings, creams, gels and including DHEA or analogues thereof)
->4 weeks for transdermal oestrogen alone or oestrogen/progestin products
->8 weeks for oral oestrogen (including selective oestrogen receptor modulators) and/or progestin therapy
->8 weeks for intrauterine progestin therapy
->3 months for progestin implants and oestrogen alone injectable drug therapy
->6 months for oestrogen pellet therapy or progestin injectable drug therapy
2.The use of non-hormonal prescription (eg paroxetine, other anti-depressants, alpha agonists [eg clonidine], methyldopa, gabapentin, pregabalin, medicinal cannabis) or over the counter/herbal treatments for treatment of menopausal symptoms is not allowed throughout the study. Subjects must have discontinued these drugs at least 28 days prior to Screening Visit 2. Subjects may, however, be permitted to continue to use these drugs if the dose has been stable for at least 4 weeks and they have been prescribed solely for the management of another disorder (e.g. neuropathic pain, depression).
3.Inability to comply with the use of prohibited medications as described below:
i.Use of digoxin is not allowed from Screening Visit 2 until 1 week after the last dose of IMP
ii.Use of known CYP3A4 substrates with a narrow therapeutic range is not allowed from Screening Visit 2 until 1 week after the last dose of IMP
iii.Use of strong or moderate inhibitors of CYP3A4 is not allowed from Screening Visit 2 until 1 week after the last dose of IMP
iv.Use of moderate or strong inducers of CYP3A4 is not allowed from Screening Visit 2 until Week 12
v.Use of known P-glycoprotein inhibitors is not allowed from Screening Visit 2 until 1 week after the last dose of IMP
4.Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of Screening Visit 1
5.Any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ECG evaluation.
6.Any clinically significant abnormal laboratory test result(s), measured at Screening Visit 2.
7.Any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms such as: infection that could have caused pyrexia, pheochromocytoma, hyperthyroidism, carcinoid syndrome, alcohol abuse.
8.Current history or previous (within the past 5 years) history of any malignancy (except basal and squamous cell skin tumours).
9.Uncontrolled hypertension
10.A history of hyperthyroidism or hypothyroidism. Treated hypothyroidism with normal thyroid function test results at Screening Visit 2 and a stable (for >3 months before Screening Visit 2) dose of replacement therapy is acceptable.
11.Known hypersensitivity to NT-814 or any of the excipients in the formulation.
12.Concurrent (or within the 2 months prior to Screening Visit 1) participation in a clinical study with an investigational medicinal product.
13.Concurrent (or within the 1 month prior to Screening Visit 1) participation in an interventional clinical study.
14.Previous participation in a clinical study with NT-814.
15.Dependent on the investigator, the contract research organisation(s) or Sponsor for education or employment.
16.Any unexplained post-menopausal bleeding.
17.Abnormal findings on mammogram or subject has not undergone a mammo
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