ISRCTN99343883已完成2 期
Phase II 6-month cyclic progesterone/spironolactone pilot therapy trial in polycystic ovary syndrome: pre-post, single-arm feasibility study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 08/12/2022:
- •1. Community dwelling
- •2. Physician diagnosed with androgenic PCOS
- •3. Ages 19-40 years (we will screen those between the ages of 35-40 for very early perimenopause (Prior JC. (2005). Clearing confusion about perimenopause. BC Medical Journal 47(10): 534-538)
- •4. If applicable, 1 month off combined hormonal contraceptives
- •5. If applicable, 1 month off metformin therapy
- •6. Not at high risk for type 2 diabetes mellitus (T2DM) (based on HbA1c >6.4%)
- •7. Not seeking fertility in the next 6-7 months
- •8. Willing to use a barrier (condoms, provided) and an applicator full of vaginal spermicide if at risk for pregnancy (sexually active with a man)
- •Previous inclusion criteria:
- •1. Community dwelling
- •2. Physician diagnosed with androgenic PCOS
- •3. Ages 19-35 years
- •4. If applicable, 1 month off combined hormonal contraceptives
- •5. If applicable, 1 month off metformin therapy
- •6. Not at high risk for type 2 diabetes mellitus (T2DM) (based on HbA1c >6.4%)
- •7. Not seeking fertility in the next 6-7 months
- •8. Willing to use a barrier (condoms, provided) and an applicator full of vaginal spermicide if at risk for pregnancy (sexually active with a man)
排除标准
- •Current exclusion criteria as of 18/03/2022:
- •1. PCOS based only on oligomenorrhea and polycystic ovary morphology without androgen excess.
- •2. High risk for type 2 diabetes mellitus based on HbA1c of 6.4 or higher
- •3. Younger than 19 years or older than age 35 years
- •4. Unwilling to stop combined hormonal contraceptives (for 1 month before joining) or other hormonal contraception (such as DepoMPA for 6 months) and during the study
- •5. Unwilling to stop metformin (for 1 month before joining) and during the study
- •4. Unwilling to stop working toward fertility for 7 months
- •5. Unwilling to use a barrier method (condom) and a whole applicator of vaginal spermicide with each intercourse (if at risk for pregnancy)
- •6. Currently breastfeeding and have been for less than 6 months
- •7. History of migraines with aura and/or neurological signs and symptoms since this brain sensitivity may mean starting or stopping progesterone could trigger a migraine
- •Previous exclusion criteria:
- •1. PCOS based only on oligomenorrhea and polycystic ovary morphology without androgen excess.
- •2. High risk for type 2 diabetes mellitus based on HbA1c of 6.4 or higher
- •3. Younger than 19 years or older than age 35 years
- •4. Unwilling to stop combined hormonal contraceptives (for 1 month before joining) or other hormonal contraception (such as DepoMPA for 6 months) and during the study
- •5. Unwilling to stop metformin (for 1 month before joining) and during the study
- •4. Unwilling to stop working toward fertility for 7 months
- •5. Unwilling to use a barrier method (condom) and a whole applicator of vaginal spermicide with each intercourse (if at risk for pregnancy)
研究者
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