Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Vaginal Cytokines at Baseline
研究概览
简要总结
The purpose of this study is to compare the vaginal health between premenopausal and postmenopausal women before and after using oral "estradiol" for 14 days then "estradiol" and "progesterone" for 14 days.
详细描述
This research project recruits 10 healthy, premenopausal women (aged 20-40 years-old) with regular menstrual cycle with interval of 24-35 days and duration of 2-7 days and 10 healthy postmenopausal women (aged 45-60 years-old) with an intact uterus and at least 12 months but not more than 36 months of spontaneous amenorrhea.
Premenopausal women will not receive any study medication(s). Postmenopausal women will be assigned the intervention described below.
• Oral "estradiol" 1.0 mg tablet for 14 days, then oral "estradiol" 1.0 mg tablet and "progesterone" 100 mg capsule for 14 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal and Postmenopausal women:
- •Female between the ages of 20 and 40 years (premenopausal arm), OR be a female between the ages of 45 and 65 years (postmenopausal arm) willing to participate in the study, as documented by signing the informed consent form.
- •Postmenopausal women with an intact uterus and at least 12 months of spontaneous amenorrhea (postmenopausal arm), OR be a premenopausal women with regular menstrual cycle with interval of 24-35 days and duration of 2-7 days (premenopausal arm).
- •No oral hormone therapy for 8 weeks and transdermal or vaginal hormone therapy for 4 week prior to the study.
- •Willing to use oral hormone therapy during the study period (postmenopausal women only).
- •Willing to abstain from using products (other than study medication) that contain estrogen, progestin, or progesterone throughout study participation.
- •Have general good health.
- •Willing to refrain from sexual intercourse for 48 hours before vaginal sample collection.
- •Willing to abstain from use of vaginal product 7 days before vaginal sample collection.
排除标准
- •To participate in the study, a subject must NOT
- •Be allergic to estrogen or progesterone products
- •Have active genital infection or inflammation based on vaginal wet preparation, power of hydrogen (pH), whiff test and potassium hydroxide (KOH) preparation 2.1 Vulvovaginal candidiasis, trichomonas vaginitis or bacterial vaginitis 2.2 Sexually transmitted diseases including herpes simplex viral infection, gonorrhea and Chlamydia
- •Have a known contraindication for oral hormone therapy or allergy to use of estradiol and/or progesterone
- •Have used estrogen alone or estrogen/progestin for any of the following time periods:
- •4.1 Vaginal hormone products (ring, cream, gels) within 30 days prior to screening 4.2 Transdermal estrogen alone or estrogen/progestin products within 4 weeks prior to screening 4.3 Oral estrogen and/or progestin therapy within 8 weeks prior to screening 4.4 Progestational implants, estrogen or estrogen/progestational injectable drug therapy within 3 months prior to screening 4.5 Estrogen pellet therapy or progestational injectable drug therapy within 6 months prior to screening 4.6 Percutaneous estrogen lotions/gels within 4 weeks prior to screening
- •Have used tamoxifen, raloxifene or other selective estrogen receptor modulators (SERMs) therapy within 8 weeks prior to screening
- •Have used an intrauterine device (IUD) within 8 weeks prior to screening
- •Have used vaginal products (pessary, tampon, tablets, douching) within 7 days prior to screening
- •Have evidence of cervical, vaginal, or vulvar intraepithelial neoplasia or cancer
- •Have a past or current history breast cancer, endometrial cancer or endometrial hyperplasia, hypertriglyceridemia or venous thromboembolism
- •Be an immuno-compromised patient including those with human immunodeficiency viral infection, chronic glucocorticoid use or active treatment with immunosuppressive agents
- •Have a history of or current evidence of thromboembolism
- •Have evidence of uncontrolled Hypertension Blood pressure >140/100 mmHg
- •Have confirmed Diabetes Mellitus
- •Currently smoking
- •For sexually active premenopausal women, should be protected against pregnancy by sterilization, condom use, abstinence, or same sex relationship
研究组 & 干预措施
2.Postmenopausal women with hormones
Oral hormone therapy will be given to women in this group. Daily dose of oral "estradiol" 1 mg will be given the first 14 days after enrollment. Then a daily dose of oral "estradiol" 1 mg and "progesterone" 100 mg for 14 days will be given during the following 14 days.
干预措施: oral estradiol 1.0 mg (Drug)
2.Postmenopausal women with hormones
Oral hormone therapy will be given to women in this group. Daily dose of oral "estradiol" 1 mg will be given the first 14 days after enrollment. Then a daily dose of oral "estradiol" 1 mg and "progesterone" 100 mg for 14 days will be given during the following 14 days.
干预措施: oral progesterone 100 mg (Drug)
结局指标
主要结局
Vaginal Cytokines at Baseline
时间窗: At baseline visit
Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women.
次要结局
- Vaginal Cytokines During Follow-up(At 14 days and 28 days follow-up)
研究者
Intira Sriprasert
Dr.
Eastern Virginia Medical School