Polycystic ovary syndrome (PCOS) Nutritional, Metabolic, Endocrine Polycystic ovarian syndrome
Conditions
Interventions
This is a prospective, open-label, single-arm, pragmatic interventional feasibility study in premenopausal women without type 2 diabetes mellitus (off combined hormonal contraceptives and/or metformin
Sponsors
Women's Health Research Institute
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/12/2021: 1. Serum luteinizing hormone (LH) measured by conventional laboratory methods and salivary free testosterone (FreeT) measured by liquid chromatography/mass spectroscopy (LC/MS-MS) in a quantitative aliquot (derived from three separate mornings’ samples) given the pulsatility of hormones in saliva) changes are compared within-woman between Phase 0 and Cycle 7 2. Salivary FreeT change measured by liquid chromatography/mass spectroscopy (LC/MS-MS) is compared within-woman between Phase 0 and Cycle 1 early follicular phase after 14 days of CyclicP4 taken in late Phase 0 to bring on menstruation 3. Weight (kg, measured using balance beam), height (m, measured using weight scale stadiometer), waist circumference (cm, measured using NIH method), blood pressure (seated, automated mean of three readings), body mass index (kg/m²), blood HbA1c (measured using standard laboratory methods), tobacco and alcohol use measured using CaMos questionnaire, and physical activity changes within-woman assessed between Cycle 1 and Cycle 7 4. Menstrual cycle lengths, variability (predictability), flow (assessed by counts of soaked standard-sized pad/tampons or by menstrual cup semi-quantitative measures) and Menstrual Cycle Diary© (Diary) experience changes recorded within-woman are compared between Phase 0 data and the mean of experiences from Cycles 1-6, and also compared between Phase 0 and Cycle 6 5. Estradiol, progesterone, cortisol and DHEA saliva data within-woman changes measured using high-throughput liquid chromatography-tandem mass spectrometry from Phase 0 to Cycle 1 (after one 14-day CyclicP4 exposure) and from Phase 0 to Cycle 7 6. Women’s Perceived Change questionnaire on acne and sleep quality, scored on a Likert Scale (-5 to 0 to +5), assessed in the follicular phase of Cycle 7 7. Generic HRQoL changes assessed within-woman using the SF-36 instrument domain scores and mental and physical summary scores from Phase 0 to Cyc | — |
Countries
Canada
Contacts
Public ContactDhani Kalidasan
Outcome results
None listed