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临床试验/NCT01942668
NCT01942668已完成3 期

A Phase 3 Study Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms in Postmenopausal Women With an Intact Uterus

TherapeuticsMD117 个研究点 分布在 1 个国家目标入组 1,845 人开始时间: 2013年8月5日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
1,845
试验地点
117
主要终点
Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter trial of postmenopausal subjects with an intact uterus.

详细描述

Postmenopausal subjects with an intact uterus who meet the study entry criteria will be randomized to one of five treatment arms (four active and one placebo) and followed for 12 months. During the Screening period all subjects will be provided with a diary to self-assess the frequency and severity of their vasomotor symptoms. Subjects experiencing a minimum daily frequency of ≥7 (or ≥50 per week) moderate to severe hot flushes will participate in a VMS Substudy during the first 12 weeks of treatment. The Substudy subjects will be stratified by treatment arm within the sites, and only Substudy subjects have the possibility of being randomized to placebo. Subjects who qualify for the study except for experiencing a minimum daily frequency of ≥7 (or ≥50 per week) moderate to severe hot flushes will be stratified within sites to one of the four active treatment arms and followed for 12 months, but will not participate in the VMS Substudy. (However, VMS information will be collected from all subjects during the first 12 weeks of treatment.) All Study Subjects: Postmenopausal women with an intact uterus who seek relief from hot flushes and meet all other inclusion/exclusion criteria are eligible for 12 months of study treatment.

VMS Substudy Subjects: A subset of All Study Subjects who have ≥7 per day or ≥50 per week moderate to severe hot flushes (as determined during Screening) are eligible for the 12-week VMS Substudy and for a total of 12 months of study treatment.

Clinical evaluations will be performed at the following time points:

  • Screening Period (Week: - 8.5) (up to -60 Days)
  • Visit 1 Randomization (Week 0) (Day 1)
  • Visit 2 Interim (Week 4)
  • Visit 3 Interim (Week 8)
  • Visit 4 Interim (Week 12)
  • Visit 5 Interim (Month 6)
  • Visit 6 Interim (Month 9)
  • Visit 7 End of Treatment (Month 12)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
40 Years 至 65 Years（Adult, Older Adult）
性别
Female
接受健康志愿者
否

入选标准

  • •Be a female between the ages of 40 and 65 years (at the time of randomization) who is willing to participate in the study, as documented by signing the informed consent form.
  • •Be a postmenopausal woman with an intact uterus and a Screening serum estradiol level of ≤50 pg/mL. Postmenopausal is defined herein as:
  • •≥ 12 months of spontaneous amenorrhea, or
  • •at least 6 months of spontaneous amenorrhea with a Screening serum FSH level of >40 mIU/ml, or
  • •≥ 6 weeks postsurgical bilateral oophorectomy.
  • •Be seeking treatment or relief for vasomotor symptoms associated with menopause.
  • •To participate in the VMS Substudy, a subject must also report ≥7 moderate to severe hot flushes per day, or ≥50 per week, at the baseline assessment during Screening (subjects whose hot flushes are less frequent may still participate as non-Substudy subjects.
  • •Note: A minimum of 14 consecutive days of complete hot flush diary data are required during the baseline assessment at Screening, and these consecutive days must occur within the last 14 days prior to the Randomization visit (not counting the Randomization visit day itself). The most recent 7 consecutive days of data prior to randomization (Day -7 to Day -1) will be used to determine the baseline number of mild, moderate and severe hot flushes for each subject.
  • •Have a Body Mass Index (BMI) less than or equal to 34 kg/mP2P. (BMI values should be rounded to the nearest integer [e.g., 34.4 rounds down to 34, while 26.5 rounds up to 27]).
  • •Be willing to abstain from using products (other than study medication) that contain estrogen, progestin, or progesterone throughout study participation.
  • •Be judged by the principal or sub-investigator physician as being in otherwise generally good health based on a medical evaluation performed during the Screening period prior to the initial dose of study medication. The medical evaluation findings must include:
  • •a normal or non-clinically significant physical examination, including vital signs (sitting blood pressure, heart rate, respiratory rate and temperature). Sitting systolic blood pressure is ≤140 mmHg and diastolic blood pressure ≤90 mmHg at Screening. A subject may be taking up to two antihypertensive medications.
  • •a normal or non-clinically significant pelvic examination.
  • •a mammogram that shows no sign of significant disease (can be performed within previous 6 months prior to initial dose of study medication). Subjects must have a BI-RADS 1 or 2 to enroll in the study. An incomplete mammogram result, i.e. BI-RADS 0, is not acceptable. The site must obtain a copy of the official report for the subject's study file, and it must be verified that the mammogram itself is available if needed for additional assessment.
  • •a normal or non-clinically significant clinical breast examination. An acceptable breast examination is defined as no masses or other findings identified that are suspicious of malignancy.
  • •a normal Screening Papanicolaou ("Pap") smear. (Subjects with findings of atypical glandular cells [AGC], AGUS, ASCUS with high risk HPV type upon reflex testing, LSIL, ASC-H, HSIL, dysplastic cells, or malignant cells must be excluded from randomization.)
  • •an acceptable result from an evaluable Screening endometrial biopsy. The endometrial biopsy reports by the two central pathologists at Screening must each specify one of the following: proliferative endometrium; weakly proliferative endometrium; disordered proliferative pattern; secretory endometrium; endometrial tissue other (including benign, inactive or atrophic fragments of endometrial epithelium, glands, stroma, etc); endometrial tissue insufficient for diagnosis; no endometrium identified; or no tissue identified. However, at least one pathologist must identify sufficient tissue to evaluate the biopsy. Additionally, the endometrial biopsy reports by the two central pathologists of Other Findings at Screening must each specify one of the following: endometrial polyp not present; benign endometrial polyp; or polyp other. (See Exclusion criterion #27)
  • •a normal or non-clinically significant 12-lead ECG.

排除标准

  • •To participate in the study, a subject must NOT:
  • •Be currently hospitalized.
  • •Have a history of thrombosis of deep veins or arteries or a thromboembolic disorder.
  • •Have a history of coronary artery or cerebrovascular disease (e.g., myocardial infarction, angina, stroke, TIA).
  • •Have a history of a chronic liver or kidney dysfunction/disorder (e.g., Hepatitis C or chronic renal failure).
  • •Have a history of a malabsorption disorder (e.g., gastric bypass, Crohn's disease).
  • •Have a history of gallbladder dysfunction/disorders (e.g., cholangitis, cholecystitis), unless gallbladder has been removed.
  • •Have a history of diabetes, thyroid disease or any other endocrinological disease. (Subjects with diet-controlled diabetes or controlled hypothyroid disease at Screening are not excluded.)
  • •Have a history of estrogen-dependent neoplasia.
  • •Have a history of atypical ductal hyperplasia of the breast.
  • •Have a finding of clinically significant uterine fibroids at Screening.
  • •Have had a uterine ablation.
  • •Have a history of undiagnosed vaginal bleeding.
  • •Have any history of endometrial hyperplasia, melanoma, or uterine/endometrial, breast or ovarian cancer.
  • •Have any history of other malignancy within the last 5 years, with the exception of basal cell (excluded if within 1 year) or non-invasive squamous cell (excluded if within 1 year) carcinoma of the skin.
  • •Have a history of any other cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological (e.g., bipolar disorder, schizophrenia, major depressive disorder), or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or Medical Sub-Investigator.
  • •Have any of the following clinical laboratory values at Screening:
  • •fasting triglyceride of ≥300 mg/dL and/or total cholesterol of ≥300mg/dL
  • •positive laboratory finding for Factor V Leiden mutation
  • •AST or ALT ≥1.5 times the upper limit of normal (ULN)
  • •fasting glucose >125 mg/dL
  • •Be known to be pregnant or have a positive urine pregnancy test. (Note: A pregnancy test is not required for subjects who have had bilateral tubal ligation, bilateral oophorectomy, or are 55 years old or greater and have experienced cessation of menses for at least 1 year.)
  • •Have contraindication to estrogen and/or progestin therapy or allergy to the use of estradiol and/or progesterone or any components of the investigational drugs.
  • •Use 15 or more cigarettes per day or currently use any electronic cigarettes.
  • •Have a history of drug and/or alcohol abuse within one year of start of study.
  • •Have used, within 28 days prior to the initial dose of study medication at Visit 1, any medication known to induce or inhibit CYP3A4 enzyme activity that may affect estrogen and/or progestin drug metabolism. (See 48TUSection 4.3U48T)
  • •Have used, within 28 days prior to Screening, or plan to use during the study, any prescription or over-the-counter (OTC) medications (including herbal products, such as St. John's Wort) that would be expected to alter progesterone or estrogen activity or is being used to treat vasomotor symptoms. (See Section 4.3U48T)
  • •Have used estrogen alone or estrogen/progestin, SERM (selective estrogen receptor modulator), testosterone, or estrogen/testosterone for any of the following time periods:
  • •Vaginal nonsystemic hormonal products (rings, creams, gels) within 7 days prior to Screening, or vaginal systemic products (e.g., FemRing) within 28 days prior to Screening.
  • •Transdermal estrogen alone or estrogen/progestin products within 8 weeks prior to Screening.
  • •Oral estrogen and/or progestin and/or SERM therapy within 8 weeks prior to Screening.
  • •Progestational implants, estrogen or estrogen/progestational injectable drug therapy within 3 months prior to Screening.
  • •Estrogen pellet therapy or progestational injectable drug therapy within 6 months prior to Screening.
  • •Percutaneous estrogen lotions/gels within 8 weeks prior to Screening.
  • •Oral, topical, vaginal, patch, implantable or injectable androgen therapy within 8 weeks prior to Screening.
  • •Have used an intrauterine device (IUD) within the 12 weeks prior to Screening.
  • •For subjects in the VMS Substudy only: use of medication that may affect the outcome of the vasomotor symptom endpoints within 28 days prior to Screening (e.g. SSRIs [selective serotonin reuptake inhibitors], SNRIs [serotonin and norepinephrine reuptake inhibitors], aldomet, dopaminergic or antidopaminergic drugs, gabapentin, clonidine, or bellergal.)
  • •Have any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study or complying with protocol requirements.
  • •Have a Screening endometrial biopsy sample that is found by both primary pathologists to have endometrial tissue insufficient for diagnosis, no endometrium identified, or no tissue identified. (With the approval of the Medical Monitor, the Screening endometrial biopsy may be repeated once.)
  • •Endometrial polyps with atypical nuclei reported by at least 1 central pathologist.
  • •Have contraindication to any planned study assessments (e.g., endometrial biopsy).
  • •Have participated in another clinical trial within 30 days prior to Screening, have received an investigational drug within the three months prior to the initial dose of study medication, or be likely to participate in a clinical trial or receive another investigational medication during the study.
  • •Currently use marijuana.

研究组 & 干预措施

Treatment 1

Experimental

Combined Estradiol 1 mg / Progesterone 100 mg softgel capsule formulation and placebo taken orally once a day for twelve months.

干预措施: Estradiol (Drug)

Treatment 1

Experimental

Combined Estradiol 1 mg / Progesterone 100 mg softgel capsule formulation and placebo taken orally once a day for twelve months.

干预措施: Progesterone (Drug)

Treatment 1

Experimental

Combined Estradiol 1 mg / Progesterone 100 mg softgel capsule formulation and placebo taken orally once a day for twelve months.

干预措施: Placebo (Drug)

Treatment 2

Experimental

Combined Estradiol 0.5 mg / Progesterone 100 mg softgel capsule formulation and placebo taken orally once a day for twelve months.

干预措施: Estradiol (Drug)

Treatment 2

Experimental

Combined Estradiol 0.5 mg / Progesterone 100 mg softgel capsule formulation and placebo taken orally once a day for twelve months.

干预措施: Progesterone (Drug)

Treatment 2

Experimental

Combined Estradiol 0.5 mg / Progesterone 100 mg softgel capsule formulation and placebo taken orally once a day for twelve months.

干预措施: Placebo (Drug)

Treatment 3

Experimental

Combined Estradiol 0.5 mg / Progesterone 50 mg softgel capsule formulation and placebo, taken orally once a day for twelve months.

干预措施: Estradiol (Drug)

Treatment 3

Experimental

Combined Estradiol 0.5 mg / Progesterone 50 mg softgel capsule formulation and placebo, taken orally once a day for twelve months.

干预措施: Progesterone (Drug)

Treatment 3

Experimental

Combined Estradiol 0.5 mg / Progesterone 50 mg softgel capsule formulation and placebo, taken orally once a day for twelve months.

干预措施: Placebo (Drug)

Treatment 4

Experimental

Combined Estradiol 0.25 mg / Progesterone 50 mg softgel capsule formulation and placebo, taken orally once a day for twelve months.

干预措施: Estradiol (Drug)

Treatment 4

Experimental

Combined Estradiol 0.25 mg / Progesterone 50 mg softgel capsule formulation and placebo, taken orally once a day for twelve months.

干预措施: Progesterone (Drug)

Treatment 4

Experimental

Combined Estradiol 0.25 mg / Progesterone 50 mg softgel capsule formulation and placebo, taken orally once a day for twelve months.

干预措施: Placebo (Drug)

Placebo

Placebo Comparator

Two Placebo softgel capsules taken orally once a day for twelve months.

干预措施: Placebo (Drug)

结局指标

主要结局

Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS)

时间窗: Baseline and Week 12

Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.

Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS)

时间窗: Baseline and Week 12

Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = \[(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of mild, moderate and severe hot flushes over 7 days).

Primary Safety Endpoint: Endometrial Protection - Hyperplasia

时间窗: Baseline and Month 12

Endometrial biopsies centrally evaluated by 2 primary pathologists using criteria from Blaustein's Pathology text. Pathologists classified bx into 1 of following 3 categories: Cat.1: Non-endometrial malignancy/non-hyperplasia; Cat.2: Endometrial hyperplasia; Cat.3: Endometrial malignancy. Consensus reached when 2 primary pathologist agreed on any of above categories; if primary pathologists disagreed on presence of hyperplasia, result of 3rd pathologist was utilized and final decision regarding presence of hyperplasia was based on diagnosis of majority. If all 3 reads disparate, final diagnosis based on most severe dx. Incidence rate calculated as: I=A/B where I=incidence rate at M12 evaluation, A=all new subjects with biopsies positive for endometrial hyperplasia during study but post-Baseline, B=all subjects w/biopsies following M11 meeting criteria specified plus all subjects w/biopsies positive for endometrial hyperplasia by any pathologists before M11.

次要结局

  • Endometrial Protection - Hyperplasia(Baseline and Month 12)
  • Frequency of Moderate to Severe Vasomotor Symptoms - Week 1 (MITT-VMS)(Baseline and Week 1)
  • Severity of Moderate to Severe Vasomotor Symptoms - Week 6 (MITT-VMS)(Baseline and Week 6)
  • Severity of Moderate to Severe Vasomotor Symptoms - Week 11 (MITT-VMS)(Baseline and Week 11)
  • Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 2 (MITT-VMS)(Baseline and Week 2)
  • Frequency of Moderate to Severe Vasomotor Symptoms - Week 2 (MITT-VMS)(Baseline and Week 2)
  • Frequency of Moderate to Severe Vasomotor Symptoms - Week 7 (MITT-VMS)(Baseline and Week 7)
  • Frequency of Moderate to Severe Vasomotor Symptoms - Week 8 (MITT-VMS)(Baseline and Week 8)
  • Frequency of Moderate to Severe Vasomotor Symptoms - Week 9 (MITT-VMS)(Baseline and Week 9)
  • Frequency of Moderate to Severe Vasomotor Symptoms - Week 11 (MITT-VMS)(Baseline and Week 11)
  • Severity of Moderate to Severe Vasomotor Symptoms - Week 5 (MITT-VMS)(Baseline and Week 5)
  • Frequency of Moderate to Severe Vasomotor Symptoms - Week 3 (MITT-VMS)(Baseline and Week 3)
  • Frequency of Moderate to Severe Vasomotor Symptoms - Week 4 (MITT-VMS)(Baseline and Week 4)
  • Frequency of Moderate to Severe Vasomotor Symptoms - Week 5 (MITT-VMS)(Baseline and Week 5)
  • Frequency of Moderate to Severe Vasomotor Symptoms - Week 6 (MITT-VMS)(Baseline and Week 6)
  • Frequency of Moderate to Severe Vasomotor Symptoms - Week 10 (MITT-VMS)(Baseline and Week 10)
  • Frequency of Moderate to Severe Vasomotor Symptoms - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Severity of Moderate to Severe Vasomotor Symptoms - Week 1 (MITT-VMS)(Baseline and Week 1)
  • Severity of Moderate to Severe Vasomotor Symptoms - Week 2 (MITT-VMS)(Baseline and Week 2)
  • Severity of Moderate to Severe Vasomotor Symptoms - Week 3 (MITT-VMS)(Baseline and Week 3)
  • Severity of Moderate to Severe Vasomotor Symptoms - Week 4 (MITT-VMS)(Baseline and Week 4)
  • Severity of Moderate to Severe Vasomotor Symptoms - Week 7 (MITT-VMS)(Baseline and Week 7)
  • Severity of Moderate to Severe Vasomotor Symptoms - Week 8 (MITT-VMS)(Baseline and Week 8)
  • Severity of Moderate to Severe Vasomotor Symptoms - Week 9 (MITT-VMS)(Baseline and Week 9)
  • Severity of Moderate to Severe Vasomotor Symptoms - Week 10 (MITT-VMS)(Baseline and Week 10)
  • Severity of Moderate to Severe Vasomotor Symptoms - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 3 (MITT-VMS)(Baseline and Week 3)
  • Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 5 (MITT-VMS)(Baseline and Week 5)
  • Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 7 (MITT-VMS)(Baseline and Week 7)
  • Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 8 (MITT-VMS)(Baseline and Week 8)
  • Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 9 (MITT-VMS)(Baseline and Week 9)
  • Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 3 (MITT-VMS)(Baseline and Week 3)
  • Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 4 (MITT-VMS)(Baseline and Week 4)
  • Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 1 (MITT-VMS)(Baseline and Week 1)
  • Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 4 (MITT-VMS)(Baseline and Week 4)
  • Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 2 (MITT-VMS)(Baseline and Week 2)
  • Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 5 (MITT-VMS)(Baseline and Week 5)
  • Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 6 (MITT-VMS)(Baseline and Week 6)
  • Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 10 (MITT-VMS)(Baseline and Week 10)
  • Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 1 (MITT-VMS)(Baseline and Week 1)
  • Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 11 (MITT-VMS)(Baseline and Week 11)
  • Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 2 (MITT-VMS)(Baseline and Week 2)
  • Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 7 (MITT-VMS)(Baseline and Week 7)
  • Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 8 (MITT-VMS)(Baseline and Week 8)
  • Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 10 (MITT-VMS)(Baseline and Week 10)
  • Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 11 (MITT-VMS)(Baseline and Week 11)
  • Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 5 (MITT-VMS)(Baseline and Week 5)
  • Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 7 (MITT-VMS)(Baseline and Week 7)
  • Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 8 (MITT-VMS)(Baseline and Week 8)
  • Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 9 (MITT-VMS)(Baseline and Week 9)
  • Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 10 (MITT-VMS)(Baseline and Week 10)
  • Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 1 (MITT-VMS)(Baseline and Week 1)
  • Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 6 (MITT-VMS)(Baseline and Week 6)
  • Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 11 (MITT-VMS)(Baseline and Week 11)
  • Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 9 (MITT-VMS)(Baseline and Week 9)
  • Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 1 - (MITT-VMS)(Baseline and Week 1)
  • Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 9 - (MITT-VMS)(Baseline and Week 9)
  • Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 12 - (MITT-VMS)(Baseline and Week 12)
  • Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 3 (MITT-VMS)(Baseline and Week 3)
  • Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 4 (MITT-VMS)(Baseline and Week 4)
  • Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 6 (MITT-VMS)(Baseline and Week 6)
  • Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 2 - (MITT-VMS)(Baseline and Week 2)
  • Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 3 - (MITT-VMS)(Baseline and Week 3)
  • Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 4 - (MITT-VMS)(Baseline and Week 4)
  • Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 6 - (MITT-VMS)(Baseline and Week 6)
  • Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 5 - (MITT-VMS)(Baseline and Week 5)
  • Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 8 - (MITT-VMS)(Baseline and Week 8)
  • Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 7 - (MITT-VMS)(Baseline and Week 7)
  • Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 10 - (MITT-VMS)(Baseline and Week 10)
  • Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 11 - (MITT-VMS)(Baseline and Week 11)
  • Clinical Global Impression (CGI) - Week 8 (MITT-VMS)(Baseline and Week 8)
  • Clinical Global Impression (CGI) - Week 4 (MITT-VMS)(Baseline and Week 4)
  • Mean Change in Frequency of Moderate to Severe VMS for the Respective CGI Category - Week 4 (MITT-VMS)(Baseline and Week 4)
  • Mean Change in Frequency of Moderate to Severe VMS for the Respective CGI Category - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Number of Subjects Without Bleeding for Consecutive Cycles(The 13th Cycle)
  • Number of Subjects With Cumulative Amenorrhea From Cycle 1 to 13(Cycle 1 to 13)
  • Mean Change in Frequency of Moderate to Severe VMS for the Respective CGI Category - Week 8 (MITT-VMS)(Baseline and Week 8)
  • Clinical Global Impression (CGI) - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Number of Subjects With Cumulative Amenorrhea From Cycle 2 to 13(Cycle 2 to 13)
  • Number of Subjects With Cumulative Amenorrhea From Cycle 3 to 13(Cycle 3 to 13)
  • Number of Subjects With Cumulative Amenorrhea From Cycle 6 to 13(Cycle 6 to 13)
  • Number of Subjects With Cumulative Amenorrhea From Cycle 10 to 13(Cycle 10 to 13)
  • Number of Subjects With Cumulative Amenorrhea From Cycle 12 to 13(Cycle 12 to 13)
  • Number of Subjects With Cumulative Amenorrhea From Cycle 7 to 13(Cycle 7 to 13)
  • Number of Days With Spotting - Trimester 1 (Safety Pop.)(Trimester 1)
  • Number of Days With Spotting - Trimester 4 (Safety Pop.)(Trimester 4)
  • Subject Incidence With Bleeding - Trimester 1 (Safety Pop.)(Trimester 1)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Month 6 (MITT-VMS)(Baseline and Month 6)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Month 12 (MITT-VMS)(Baseline and Month 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Month 12 (MITT-VMS)(Baseline and Month 12)
  • Number of Subjects With Cumulative Amenorrhea From Cycle 4 to 13(Cycle 4 to 13)
  • Number of Subjects With Cumulative Amenorrhea From Cycle 5 to 13(Cycle 5 to 13)
  • Number of Subjects With Cumulative Amenorrhea From Cycle 8 to 13(Cycle 8 to 13)
  • Number of Subjects With Cumulative Amenorrhea From Cycle 9 to 13(Cycle 9 to 13)
  • Number of Subjects With Cumulative Amenorrhea From Cycle 11 to 13(Cycle 11 to 13)
  • Number of Subjects With Cumulative Amenorrhea From the 13th Cycle(The 13th Cycle)
  • Subject Incidence With Spotting - Trimester 4 (Safety Pop.)(Trimester 4)
  • Number of Days With Spotting - Trimester 2 (Safety Pop.)(Trimester 2)
  • Subject Incidence With Bleeding - Trimester 2 (Safety Pop.)(Trimester 2)
  • Number of Days With Bleeding - Trimester 1 (Safety Pop.)(Trimester 1)
  • Number of Days With Bleeding - Trimester 2 (Safety Pop.)(Trimester 2)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Month 6 (MITT-VMS)(Baseline and Month 6)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Subject Incidence With Spotting - Trimester 3 (Safety Pop.)(Trimester 3)
  • Number of Days With Spotting - Trimester 3 (Safety Pop.)(Trimester 3)
  • Subject Incidence With Bleeding - Trimester 4 (Safety Pop.)(Trimester 4)
  • Subject Incidence With Spotting - Trimester 1 (Safety Pop.)(Trimester 1)
  • Subject Incidence With Spotting - Trimester 2 (Safety Pop.)(Trimester 2)
  • Subject Incidence With Bleeding - Trimester 3 (Safety Pop.)(Trimester 3)
  • Number of Days With Bleeding - Trimester 3 (Safety Pop.)(Trimester 3)
  • Number of Days With Bleeding - Trimester 4 (Safety Pop.)(Trimester 4)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Month 12 (MITT-VMS)(Baseline and Month 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Month 6 (MITT-VMS)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Month 6 (MITT-VMS)(Baseline and Month 6)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Month 12 (MITT-VMS)(Baseline and Month 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Month 6 (MITT-VMS)(Baseline and Month 6)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Month 12 (MITT-VMS)(Baseline and Month 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Month 12 (MITT-VMS)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Month 6 - (MITT-VMS)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Month 6 - (MITT-VMS)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Week 12 - (MITT-VMS)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Month 6 - (MITT-VMS)(Baseline and Month 6)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Week 12 (MITT)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Month 6 (MITT-VMS)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Month 12 - (MITT-VMS)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Week 12 - (MITT-VMS)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Month 12 - (MITT-VMS)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Week 12 - (MITT-VMS)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Month 12 - (MITT-VMS)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Week 12 (MITT-VMS)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Month 12 - (MITT-VMS)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Week 12 - (MITT-VMS)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Month 6 - (MITT-VMS)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Week 12 - (MITT-VMS)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Optimal Sleep - Month 12 - (MITT-VMS)(Baseline and Month 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Month 12 (MITT)(Baseline and Month 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Week 12 (MITT)(Baseline and Week 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Month 12 (MITT)(Baseline and Month 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Week 12 (MITT)(Baseline and Week 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Month 6 (MITT)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Month 6 - (MITT-VMS)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Month 12 - (MITT-VMS)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Month 6 - (MITT-VMS)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Month 6 - (MITT-VMS)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Month 12 - (MITT-VMS)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Optimal Sleep - Week 12 - (MITT-VMS)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Optimal Sleep - Month 6 - (MITT-VMS)(Baseline and Month 6)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Month 6 (MITT)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Week 12 - (MITT-VMS)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Month 12 - (MITT-VMS)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Month 6 - (MITT)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Optimal Sleep - Week 12 - (MITT)(Baseline and Week 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Month 12 (MITT)(Baseline and Month 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Week 12 (MITT)(Baseline and Week 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Month 6 (MITT)(Baseline and Month 6)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Month 12 (MITT)(Baseline and Month 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Month 6 (MITT)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Month 12 - (MITT)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Week 12 - (MITT)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Month 12 - (MITT)(Baseline and Month 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Week 12 (MITT)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Month 12 - (MITT)(Baseline and Month 12)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Month 6 (MITT)(Baseline and Month 6)
  • Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Month 12 (MITT)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Week 12 - (MITT)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Month 12 - (MITT)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Week 12 (MITT)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Month 6 (MITT)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Month 12 (MITT)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Month 6 - (MITT)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Week 12 - (MITT)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Week 12 - (MITT)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Month 6 - (MITT)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Month 12 - (MITT)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Week 12 - (MITT)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Month 12 - (MITT)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Month 12 - (MITT)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Month 6 - (MITT)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Month 6 - (MITT)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Week 12 - (MITT)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Month 6 - (MITT)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Week 12 - (MITT)(Baseline and Week 12)
  • Medical Outcomes Sleep Study (MOS) Optimal Sleep - Month 12 - (MITT)(Baseline and Month 12)
  • Medical Outcomes Sleep Study (MOS) Sleep Problems Index II - Month 6 - (MITT)(Baseline and Month 6)
  • Medical Outcomes Sleep Study (MOS) Optimal Sleep - Month 6 - (MITT)(Baseline and Month 6)

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