Treatment of hepatic steatosis related oligo-ovulation
A technology of visceral fat and liver, applied in the field of treatment or prevention of PCOS and PCOS-like symptoms
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Embodiment 1
[0074] Example 1: Treatment with low dose spironolactone pioglitazone metformin for adolescent girls / young women with hyperinsulinemic hyperandrogenism.
[0075] method
[0076] Research plan and object
[0077]Table 1 summarizes the randomized, single-centre, open-label study plan over 24 months.
[0078] The study subjects included 36 Catalan girls who fulfilled four selection criteria for hirsutism (Freeman-Galway scale score >8), oligomenorrhea (menstrual interval >45 days), gynecological age ( or time since menarche) > 2.0 years, and no sexual activity (not requiring contraception).
[0079] The girls were recruited between January 2013 and May 2014 at the Department of Adolescent Endocrinology, Sant Joan of Arc University Hospital, Barcelona, Spain (matching flowchart; Figure 6 ). Recruitment was biased against overweight / obesity because, in our setting, overweight / obese adolescent girls were primarily referred to obesity rather than adolescent endocrinology.
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Embodiment 2
[0118] Embodiment 2: tablet
[0119] For the manufacture of the tablets, the active substances spironolactone, metformin and pioglitazone are mixed with polyvinylpyrrolidone. Low shear wet granulation is performed and the resulting granules are dried and milled. The remaining excipients (croscarmellose sodium, microcrystalline cellulose, magnesium stearate and polyvinyl alcohol) were mixed with the milled granules and mixed together with the lubricant polyvinyl alcohol. Finally the mixture was compressed into tablets having the following composition.
[0120] The prepared tablet core comprises:
[0121] tablet core
Quantity / mg
Features
core
spironolactone
50
active ingredients
pioglitazone
7.5
active ingredients
850
active ingredients
55
30
Thinner
70
disintegrant
Ma...
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