EUCTR2021-000059-38-DKActive, not recruitingPhase 1
A double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women. - OASIS 3
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Bayer Consumer Care AG
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1. Females aged 40 to 65 years, inclusive, at signing of informed consent.
- •2. Postmenopausal, defined as:
- •a. at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or
- •b. at least 6 months of spontaneous amenorrhea prior to signing of informed consent with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or
- •c. at least 6 months after hysterectomy at signing of informed consent with serum FSH levels > 40 mIU/mL^2 and a serum estradiol concentration of < 30 pg/mL, or
- •d. surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to signing of informed consent.
- •3. Moderate to severe hot flash (HF) associated with the menopause and seeking treatment for this condition.
- •4. Negative urine pregnancy test at Screening.
- •5. In good general health, in the opinion of the investigator, based on the medical history, physical examination, 12-lead ECG, BMD, vital signs, gynecological ultrasound, endometrial biopsy, mammogram, clinical laboratory tests, eC-SSRS, and other assessments completed during screening.
- •6. Normal or clinically insignificant cervical cytology not requiring further follow-up:
- •a. A cervical cytology sample has to be obtained during screening, or
- •b. A documented normal result has to be available from cervical cytology conducted within 12 months prior to signing of informed consent.
- •c. HPV testing in participants with ASCUS will be used as an adjunctive test automatically. Participants with ASCUS can be included if they are negative for high-risk HPV strains.
- •7. BMI between 18 and 38 kg/m2 at screening
- •8. Participant has a screening mammogram performed, unless she is able to provide a written normal mammogram result obtained no more than 6 months prior to the start of screening.
- •9. Participant has completed HFDD for at least 11 days during the two weeks preceding baseline visit.
- •10. Capable of giving signed informed consent
- •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 588
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
Exclusion Criteria
- •1. Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on ECG evaluation.
- •2. Any clinically significant abnormal laboratory test result(s) measured during screening (single re-test allowed, except for tests listed inclusion criteria 2 and exclusion criteria 10).
- •3. Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms (VMS) such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome.
- •4. Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors). Women receiving adjuvant endocrine therapy (e.g. tamoxifen, aromatase inhibitors, GnRH analogues) cannot be enrolled in this study.
- •5. Uncontrolled or treatment-resistant hypertension. Women with mild hypertension can be included in the study if they are medically cleared prior to study participation.
- •6. Untreated hyperthyroidism or hypothyroidism. Treated
- •hyperthyroidism with no abnormal increase of thyroid function laboratory parameters and no relevant clinical signs for > 6 months
- •before signing of informed consent is acceptable. Treated hypothyroidism with normal thyroid function test results during screening and a stable (for > 3 months before signing of informed consent) dose of replacement therapy is acceptable.
- •7. Any unexplained post-menopausal uterine bleeding.
- •8. Clinically relevant abnormal findings on mammogram.
- •9. Renal impairment greater than moderate (i.e. estimated glomerular filtration rate
- •< 30 mL/min/1.73m2) at screening
- •10. Abnormal liver parameters.
- •11. Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening.
- •12. Any other history, condition, therapy, or uncontrolled intercurrent illness which could in the opinion of the investigator affect compliance with study requirements.
- •13. Has used and is unwilling to wash-out use of any of the prohibited concomitant medications.
- •14. Inability to comply with the use of prohibited medications.
Investigators
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