A 60-month Non-comparative Study on Bleeding Profiles With Levonorgestrel Intrauterine System in Transition From Reproductive Age Contraception to Menopause Age Endometrial Protection During Estrogen Replacement Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 394
- 主要终点
- Number of Bleeding Days
研究概览
简要总结
The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest in the study is the pattern of any vaginal bleeding that occurs.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 46 Years 至 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms.
排除标准
- •Pregnancy or lactation.
- •Previous pelvic infections.
- •Abnormal bleeding.
- •Abnormal uterine cavity.
- •Uterine polyps.
- •Genital cancer.
- •Liver diseases.
- •Alcoholism or drug abuse.
研究组 & 干预措施
LNG IUS
Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
干预措施: LNG IUS (Drug)
结局指标
主要结局
Number of Bleeding Days
时间窗: Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase
Measured by using Subject Diaries (Subject Reported Data)
Number of Spotting Days
时间窗: Last 90 days in Contraception Phase and first 360 days in HRT Phase
Measured by using Subject Diaries (Subject Reported Data)
Percentage of Participants With Successful Treatment
时间窗: Last 90 days in Contraception Phase and first 360 days in HRT Phase
Definition of successful treatment: * Completion of HRT phase, and * Both, the number of bleeding days and the number of spotting days during HRT was equal to or less than during contraceptive phase, and * The number of bleeding days and the number of spotting days could be calculated for at least 3 out of the first 4 reference periods in HRT
次要结局
- Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Climacteric Symptom 5: Irritability (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Climacteric Symptom 6: Breast Tension (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Assessment of QOL as Measured by Women's Health Questionnaire(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Continuation Rates(At entry, at 2 years, at 4 years)
- Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Progestogenic Symptom 4: Nausea (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Progestogenic Symptom 5: Edema (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)
- Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)(Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase)