EUCTR2017-000142-22-DE进行中（未招募）1 期
Assessment of therapeutical equivalence of a newly developed vaginal tablet containing 10 µg of estradiol in comparison with a marketed reference product (Vagifem®) – a double-blind, double-dummy, multiple dose, parallel-group, placebo- and active-controlled trial with additional characterisation of systemic exposure in postmenopausal female volunteers suffering from vaginal atrophy - Therapeutical equivalence of estradiol vaginal tablets in postmenopausal women with vaginal atrophy
Helm AG0 个研究点目标入组 50 人开始时间: 2017年4月13日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Age: 18 years or older
- •2. Good state of health commensurate with age
- •3. Postmenopausal state defined as follows:
- •- last spontaneous menstruation at least 1 year prior to the study and FSH (plasma) >= 40 IU/l, estradiol (serum) <= 20 pg/ml, or
- •- bilateral ovariectomy with or without hysterectomy at least 3 months prior to individual enrolment
- •4. Maturation value = 50 %
- •5. Vaginal pH > 5.0
- •6. Investigator’s assessment of vaginal health: visually assessed signs of vaginal atrophy (a thinned vaginal mucosa or a mucosa with flattening of folds; a dry, fragile, or pale vaginal mucosa; the presence of petechiae or any other alteration that the investigator considers indicative of vaginal atrophy)
- •7. At least one urogenital symptom self-assessed by the subjects (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia, vaginal bleeding associated with sexual activity, recurrent vaginal infections, hyperactive bladder with urge incontinence or stress incontinence
- •8. Non-smoker or ex-smoker for at least 6 months
- •9. Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in this clinical trial
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Safety concerns
- •1. Existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- •2. Existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
- •3. History of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- •4. Known allergic reactions/hypersensitivity to the active ingredient used or to constituents of the pharmaceutical preparations
- •5. Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
- •6. Systolic blood pressure > 145 mmHg
- •7. Diastolic blood pressure >90 mmHg
- •8. Pulse rate < 50 bpm or > 100 bpm
- •9. Any laboratory value outside of normal and judged by investigator as relevant for participation under safety considerations
- •10. Any further contraindication to estrogen therapy
- •- Known, past or suspected breast cancer
- •- Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)
- •- Genital bleeding
- •- Untreated endometrial hyperplasia
- •- Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)
- •- Known thrombophilic disorders
- •- Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
- •- Porphyria
- •11. If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment
- •- Leiomyoma (uterine fibroids) or endometriosis
- •- Risk factors for thromboembolic disorders
- •- Risk factors for oestrogen-dependent tumours, e.g. 1st degree heredity for breast cancer
- •- Untreated or uncontrolled hypertension
- •- Liver disorders (e.g. liver adenoma)
- •- Diabetes mellitus with or without vascular involvement
- •- Cholelithiasis
- •- Migraine or (severe) headache
- •- Systemic lupus erythematosus
- •- A history of endometrial hyperplasia
- •- Epilepsy
- •- Otosclerosis
- •12. Diagnosis of a cervical smear: findings classified in a group higher than IIa according to the Munich III nomenclature (or corresponding findings according to the Bethesda system)
- •13. For females with an intact uterus: no confirmation of an inactive endometrial lingering and/or endometrial thickness of =5 mm
- •14. Vaginal infection requiring further treatment
- •15. Hormone replacement therapy, therapy with phytoestrogens, local vaginal hormonal therapy or other drugs acting on the estrogen receptor within 3 months prior to first IMP administration (e.g. diethylstilbestrol, tibolone, SERM)
- •16. Use of systemic or intravaginal corticosteroids within 8 weeks prior to first IMP administration
- •Lack of suitability for the clinical trial
- •17. Acute or chronic diseases which may interfere with the pharm
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