Cyclic progesterone and spironolactone treatment for androgenic polycystic ovary syndrome
- Conditions
- Polycystic ovary syndrome (PCOS)Nutritional, Metabolic, EndocrinePolycystic ovarian syndrome
- Registration Number
- ISRCTN99343883
- Lead Sponsor
- Women's Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 41
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)
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
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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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Health-related quality of life (HRQoL) change is measured within-woman with androgenic PCOS by the PCOS-Questionnaire© (PCOS-Q) instrument comparing the total score, and domain-specific scores between Phase 0 (screening, random cycle day) and the early follicular phase of Cycle 7 (study end) after 6-months’ treatment with cyclic progesterone (CyclicP4) and 5-months’ treatment with spironolactone (Sp) therapies
- Secondary Outcome Measures
Name Time Method