An Open-labeled Pilot Study to Determine the Efficacy of an E2//Nomegestrol Acetate (E2/NOMAC)Combination Oral Contraceptive (COC) in the Management of Heavy Menstrual Bleeding (HMB)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- • The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline
研究概览
简要总结
Women with measured menstrual bleeding >80ml per cycle and no contraindications to combined oral contraceptive use will be assigned to an oestradiol/nomegestrol acetate oral contraceptive for 3 cycles during which they will collect all menstrual blood and send all used sanitary protection to the laboratory at the University of Sydney for estimation of blood loss by the alkaline haematin method.
Hypothesis:
An estradiol/nomogestrel acetate (E2/NOMAC) combined pill will be effective in controlling HMB in the majority of women without structural pelvic pathology.
Main outcome:
The primary efficacy end-point will be the proportion of women with a reduction of menstrual blood loss ≥ 50% from baseline.
详细描述
Women will collect menstrual blood for 3 cycles and will be eligible to enter the treatment phase if in two of the three pre-treatment cycles the measured menstrual blood loss (MBL)is >80ml. The mean of these baseline MBL measurements will be the comparator for the efficacy treatment measurement. Iron studies (serum ferritin, Fe and transferrin) will also be measured pre and post treatment and related to women's assessment of their quality of life measured on a validated questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-50 years having regular menstrual cycles
- •Women willing to collect all sanitary protection for 6 cycles
- •Women with no contraindications to use of combined hormonal contraception
- •Women not using any hormonal contraception or any treatment for HMB
- •Women who have no demonstrable uterine pathology on pelvic ultrasound
- •Women who have demonstrated a menstrual blood loss (MBL) >80mls in 2 of 3 menstrual periods during the pre-treatment phase will be eligible to enter the treatment phase
排除标准
- •Women for whom combined oral contraceptives are contraindicated
- •Women unwilling to collect all sanitary protection for 6 cycles
- •Women using hormonal contraception or any treatment for HMB
- •Women who have demonstrable uterine pathology on pelvic ultrasound
- •Women who have demonstrated a MBL ≤80mls in 2 of 3 consecutive menstrual periods
研究组 & 干预措施
E2/Nomac
Women with demonstrated HMB at baseline will be assigned to 3 cycles of a E2/Nomac combined pill 1 daily for 24 days followed by 1 placebo pill daily for 4 days per cycle.
干预措施: E2Nomac (Drug)
结局指标
主要结局
• The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline
时间窗: Baseline to outcome 12weeks
A single arm open label intervention study
次要结局
- •• A secondary efficacy endpoint will be the number and proportion of cycles with a normal blood loss ≤ 80mls(•Baseline to endpoint 12 weeks)