Troglitazone Improves Ovulation and Hirsutism In Women With Polycystic Ovary Syndrome

Apr 11, 2001, 01:00 ET from The Endocrine Society

    BETHESDA, Md., April 11 /PRNewswire/ -- A new study, published in the
 April issue of the Journal of Clinical Endocrinology & Metabolism, shows that
 troglitazone, an insulin-sensitizing agent and member of the thiazolidinedione
 class of drugs, improves ovulation and hirsutism in women who suffer from
 Polycystic Ovary Syndrome (PCOS), an endocrine disorder that effects seven to
 10 percent of reproductive-age women.
     "This study is the first trial of its size that shows long term changes in
 ovulatory function in women with PCOS," said Dr. Mahmoud Ghazzi, MD, PhD, a
 researcher and Senior Director of the Endocrine and Metabolism division at
 Pfizer Inc, (Parke-Davis, which funded the study, was a division of Warner-
 Lambert, which merged with Pfizer Inc in June 2000).  "Additionally, this
 study is the first to show that using an insulin sensitizing agent results in
 improvement in hirsutism, which is often associated with PCOS."
     The multicenter, double blind, placebo-controlled trial studied four
 hundred and ten premenopausal women with PCOS over 44 weeks.  The subjects
 received either a placebo or troglitazone in doses of 150 mg, 300 mg or 600 mg
 per day.
     Researchers at the University of Alabama, the University of Chicago
 Medical Center, Penn State University, Parke-Davis Pharmaceuticals and other
 academic institutions compared changes in ovulatory function, hirsutism,
 hormone levels and glycemic parameters in the different groups.  They found
 that the patients who received 300 or 600 mg of troglitazone experienced
 significantly greater ovulatory rates compared with the placebo group.  For
 example, 57 percent of the women who received 600 mg of troglitazone ovulated
 50 percent of the time, compared with only 12 percent of the time in the
 placebo group.
     The study also showed a significant decrease in the Ferriman-Gallwey
 score, which measures hirsutism in women, in the 600 mg group.  In addition,
 the women who took troglitazone experienced a decrease in free testosterone
 and an increase in sex hormone-binding globulin.  Glycemic parameters also
 showed a dose-related decrease in the women who took troglitazone.
     "This research clearly demonstrates the therapeutic effects of
 ameliorating Hyperinsuliniemia, which include using an agent like
 troglitazone, to improve ovulatory dysfunction in women with PCOS," said Dr.
 Ghazzi.  "Hopefully, these findings will help us better understand the
 mechanisms involved in PCOS and identify new ways to more effectively treat
 women who suffer from the devastating effects of PCOS.  Additionally, since
 troglitazone is no longer available on the market, it would be tempting to
 conclude that other members of the same class (PPARy agonists) might have
 similar effects.  However, further studies using those agents are needed to
 validate such a conclusion."
 
     JCEM is one of four journals published by The Endocrine Society.   Founded
 in 1916, The Endocrine Society is the world's oldest, largest, and most active
 organization devoted to research on hormones, and the clinical practice of
 endocrinology.  Today, The Endocrine Society's membership consists of over
 9,000 scientists, physicians, educators, nurses and students, in more than 80
 countries.  Together, these members represent all basic, applied, and clinical
 interests in endocrinology.  The Endocrine Society is based in Bethesda,
 Maryland.  To learn more about the Society, and the field of endocrinology,
 visit the Society's Web site at http://www.endo-society.org .
 
 

SOURCE The Endocrine Society
    BETHESDA, Md., April 11 /PRNewswire/ -- A new study, published in the
 April issue of the Journal of Clinical Endocrinology & Metabolism, shows that
 troglitazone, an insulin-sensitizing agent and member of the thiazolidinedione
 class of drugs, improves ovulation and hirsutism in women who suffer from
 Polycystic Ovary Syndrome (PCOS), an endocrine disorder that effects seven to
 10 percent of reproductive-age women.
     "This study is the first trial of its size that shows long term changes in
 ovulatory function in women with PCOS," said Dr. Mahmoud Ghazzi, MD, PhD, a
 researcher and Senior Director of the Endocrine and Metabolism division at
 Pfizer Inc, (Parke-Davis, which funded the study, was a division of Warner-
 Lambert, which merged with Pfizer Inc in June 2000).  "Additionally, this
 study is the first to show that using an insulin sensitizing agent results in
 improvement in hirsutism, which is often associated with PCOS."
     The multicenter, double blind, placebo-controlled trial studied four
 hundred and ten premenopausal women with PCOS over 44 weeks.  The subjects
 received either a placebo or troglitazone in doses of 150 mg, 300 mg or 600 mg
 per day.
     Researchers at the University of Alabama, the University of Chicago
 Medical Center, Penn State University, Parke-Davis Pharmaceuticals and other
 academic institutions compared changes in ovulatory function, hirsutism,
 hormone levels and glycemic parameters in the different groups.  They found
 that the patients who received 300 or 600 mg of troglitazone experienced
 significantly greater ovulatory rates compared with the placebo group.  For
 example, 57 percent of the women who received 600 mg of troglitazone ovulated
 50 percent of the time, compared with only 12 percent of the time in the
 placebo group.
     The study also showed a significant decrease in the Ferriman-Gallwey
 score, which measures hirsutism in women, in the 600 mg group.  In addition,
 the women who took troglitazone experienced a decrease in free testosterone
 and an increase in sex hormone-binding globulin.  Glycemic parameters also
 showed a dose-related decrease in the women who took troglitazone.
     "This research clearly demonstrates the therapeutic effects of
 ameliorating Hyperinsuliniemia, which include using an agent like
 troglitazone, to improve ovulatory dysfunction in women with PCOS," said Dr.
 Ghazzi.  "Hopefully, these findings will help us better understand the
 mechanisms involved in PCOS and identify new ways to more effectively treat
 women who suffer from the devastating effects of PCOS.  Additionally, since
 troglitazone is no longer available on the market, it would be tempting to
 conclude that other members of the same class (PPARy agonists) might have
 similar effects.  However, further studies using those agents are needed to
 validate such a conclusion."
 
     JCEM is one of four journals published by The Endocrine Society.   Founded
 in 1916, The Endocrine Society is the world's oldest, largest, and most active
 organization devoted to research on hormones, and the clinical practice of
 endocrinology.  Today, The Endocrine Society's membership consists of over
 9,000 scientists, physicians, educators, nurses and students, in more than 80
 countries.  Together, these members represent all basic, applied, and clinical
 interests in endocrinology.  The Endocrine Society is based in Bethesda,
 Maryland.  To learn more about the Society, and the field of endocrinology,
 visit the Society's Web site at http://www.endo-society.org .
 
 SOURCE  The Endocrine Society