A Phase 2b, Double-blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the 12-week Efficacy of Vagitocin in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy

PEPTONIC medical AB0 个研究点目标入组 200 人开始时间: 2016年1月29日最近更新: 2017年10月30日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: PEPTONIC medical AB
入组人数: 200

研究概览入排标准研究者记录与标识符相似试验

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

性别: Female

入选标准

•The patients have to meet all of the following criteria to be eligible to enter the study:
•1.Females aged 40-65 years at the time of screening, who are willing to participate in the study as indicated by signing the informed consent.
•2.Postmenopausal women with at least 24 months of spontaneous amenorrhea, or women who have had surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks ago.
•3.Have = 5% superficial cells in vaginal smear cytology at screening.
•4.Have a vaginal pH > 5.0 at screening.
•6.Have one moderate to severe vulvovaginal atrophy symptom (vulvar/vaginal irritation and itching, vaginal dryness, dysuria, dyspareunia or presence of vaginal bleeding associated with vaginal sexual activity [yes/no]) that has been identified by the subject as being the most bothersome to her.
•7.Have a body mass index =32 kg/m2.
•8.Be judged by the Principal Investigator or Sub-investigator as being in otherwise good health based on a pre-study medical evaluation performed within 21 days prior to the initial dose of study medication. The medical evaluation findings must include:
•a.A normal or clinically non-significant finding at physical examination.
•b.A normal or clinically non-significant heart rate.
•c.A mean sitting systolic blood pressure =150 mm Hg and diastolic blood pressure =90 mm Hg at screening. Hypertensive subjects controlled with stable medications, who have a blood pressure =150 mm Hg (systolic) and = 90 (diastolic) mm Hg are suitable for inclusion.
•d.A normal or clinically non-significant finding at gynaecological examination.
•e.A normal mammography that has been performed within 36 months prior to initial dose of study medication. A normal mammogram is defined as a mammogram in which no masses or other findings are diagnosed which are suspected of being malignant. The investigational site has to make all possible efforts to obtain a copy of the official mammography report, or an oral statement from the mammography clinic, for the subject's study file.
•f.A normal or clinically non-significant finding at clinical breast examination. An acceptable breast examination is defined as an examination in which no masses or other findings are identified which are suspected of being malignant.
•g.An acceptable Papanicolaou (Pap”) smear for subjects with an intact uterus and cervix (can be performed within previous 6 months prior to initial dose of study medication). An acceptable cervical smear is defined as a smear in which no dysplastic or malignant cells are identified.
•h.Laboratory values within normal limits or with non-significant deviations from normal values.
•9.Have an endometrial thickness of < 4 mm as determined by vaginal ultrasonography, in women with an intact uterus.
•10.Be willing to abstain from vaginal sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and at Visits 2 and 3.
•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 200
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•Patients meeting any of the following criteria will not be permitted to enter the study:
•1.Currently hospitalized.
•2.Have a history or ongoing cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator.
•3.Have had or have any known or suspected tumour disease that is clinically significant in the opinion of the Principal Investigator or Sub-Investigator.
•4.Have a history of endometrial hyperplasia or uterine/endometrial, breast or ovarian cancer.
•5.Have a history of undiagnosed vaginal bleeding.
•6.Have an ongoing urogenital infection in spite of treatment at the randomization visit.
•7.Any contraindication to oxytocin therapy and allergy to the use of oxytocin and any components of the investigational drugs.
•8.Have a history of drug and/or alcohol abuse within one year of start of study.
•9.Have used any prescription or over the counter (OTC) medications including phytoestrogens, herbal medicinal products or hormonal intra-uterine device with known estrogenic effects within 12 weeks prior to the screening visit.
•10.Have used any type of vaginal lubricants and moisturizers within 24 hours prior to the screening Visit.
•11.Have used estrogen alone or estrogen/progestin for any of the following time periods:
•a.Vaginal hormonal products (rings, creams, gels, vaginal suppositories) within 12 weeks prior to the screening visit;
•b.Transdermal estrogen alone or estrogen/progestin products including percutaneous estrogen gels for at least 12 weeks prior to the screening visit;
•c.Oral estrogen and/or progestin therapy within 12 weeks prior to the screening visit;
•d.Intrauterine progestin therapy within 12 weeks prior to the screening visit;
•e.Progestin implants and estrogen alone injectable drug therapy within 12 weeks prior to the screening visit;
•f.Estrogen pellet therapy or progestational injectable drug therapy within 6 months prior to the Screening visit.
•12.Have any reason, which in the opinion of the Principal Investigator or Sub-Investigator would prevent the subject from safely participating in the study or complying with protocol requirements.
•13.Have participated in another clinical study within 90 days prior to screening, have received an investigational drug within three months prior to the initial dose of study medication, or be likely to participate in another clinical study or receive another investigational medication during the study.
•14.Have contraindication to any planned study procedure.
•15.Pregnancy.

研究者

发起方

PEPTONIC medical AB

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