DHEA and Vaginal Atrophy
The use of Intravaginal DHEA as a suitable treatment for women who suffer from vaginal atrophy and have a history of cancer. These women typically cannot use estrogen-related hormones to provide relief from a very uncomfortable condition that affects about 5% of menopausal women. Besides hampering intercourse vaginal atrophy can progress as to cause pain with common activities such as walking. This group studied the effect that DHEA had on vaginal tissue integrity when applied intravaginally. They found that it improved vaginal skin tone by causing a dramatic increase in Parabasal cells, an increase in superficial cells and an impressive lowering of ph. Further study showed that the intravaginal DHEA was able to” improve sexual function and caused no or minimal changes in serum sex steroid levels”. This is important because changes in serum sex steroid levels are the concern of women who have had cancer and it is these changes in serum sex steroid levels that prevents women with a history of cancer from using estrogen.
Menopause. 2009 May 8. [Epub ahead of print]
Intravaginal dehydroepiandrosterone (Prasterone), the physiological and a highly efficient treatment of vaginal atrophy.
Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J.
From the 1Laval University Hospital Research Center and Laval University, Quebec, Canada; 2Endoceutics Inc., Quebec City, QC, Canada;3Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA; 4Clinique de Recherche en Santé des Femmes, Quebec City, Canada; 5Diex Recherche Inc., Sherbrooke, QC, Canada; 6Rapid Medical Research Inc., Cleveland, OH;7Clinique Gynécologique, Shawinigan, Canada; 8Montreal Clinical Study Center, Montreal, Canada; 9Centre Hospitalier affilié Universitaire de Québec, Quebec City, Canada; 10McGill University Health Center, Royal Victoria Hospital, Montreal, QC, Canada; and 11Veristat Inc., Boston, MA.
OBJECTIVE:: Because the secretion of dehydroepiandrosterone (DHEA), the exclusive source of sex steroids in postmenopausal women, is already decreased by 60% and continues to decline at the time of menopause, the objective of this study was to examine the effect of intravaginal DHEA on the symptoms and signs of vaginal atrophy. METHODS:: This prospective, randomized, double-blind and placebo-controlled phase III clinical trial studied the effect of Prasterone (DHEA) applied locally in the vagina on the signs and symptoms of vaginal atrophy in 216 postmenopausal women. RESULTS:: All three doses (0.25%, 0.5%, and 1.0%) of DHEA ovules applied daily intravaginally induced a highly significant beneficial change in the percentage of vaginal parabasal and superficial cells and pH as well as in the most bothersome symptom at 2 weeks. At the standard 12-week time interval, 0.5% DHEA caused a 45.9 +/- 5.31 (P < 0.0001 vs placebo) decrease in the percentage of parabasal cells, a 6.8 +/- 1.29% (P < 0.0001) increase in superficial cells, a 1.3 +/- 0.13 unit (P < 0.0001) decrease in vaginal pH, and a 1.5 +/- 0.14 score unit (P < 0.0001) decrease in the severity of the most bothersome symptom. Similar changes were seen on vaginal secretions, color, epithelial surface thickness, and epithelial integrity. Comparable effects were observed at the 0.25% and 1.0% DHEA doses. CONCLUSIONS:: Local Prasterone, through local androgen and estrogen formation, causes a rapid and efficient reversal of all the symptoms and signs of vaginal atrophy with no or minimal changes in serum steroids, which remain well within the normal postmenopausal range. This approach avoids the fear of systemic effects common to all presently available estrogen formulations and adds a novel physiological androgenic component to therapy.
PMID: 19436225 [PubMed - as supplied by publisher
Menopause. 2009 May 8. [Epub ahead of print]
Serum steroid levels during 12-week intravaginal dehydroepiandrosterone administration.
Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté I, Labrie C, Lavoie L, Bérubé R, Bélanger P, Berger L, Gilbert L, Martel C, Balser J.
From the 1Laval University Hospital Research Center and Laval University, Quebec, Canada; 2Endoceutics Inc., Quebec City, QC, Canada; 3Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA; 4Clinique de Recherche en Santé des Femmes, Quebec City, Canada; 5Diex Recherche Inc., Sherbrooke, QC, Canada; 6Rapid Medical Research Inc.,Cleveland, OH; 7Clinique Gynécologique, Shawinigan, Canada; 8Montreal Clinical Study Center, Montreal, Canada; 9Centre Hospitalier Affilié Universitaire de Québec, Quebec City, Canada; 10McGill University Health Center, Royal Victoria Hospital, Montreal, QC, Canada; and 11Veristat Inc., Boston, MA.
OBJECTIVE:: Because a previous 1-week study has shown no or minimal changes in the serum levels of dehydroepiandrosterone (DHEA) and its metabolites after up to daily 1.8% (23.4 mg) intravaginal DHEA, the objective of the present study was to investigate the serum steroid levels during a 12-week daily intravaginal administration of 0%, 0.25%, 0.5%, and 1.0% DHEA (Prasterone) 1.3 mL ovules. METHODS:: In a double-blind, placebo-controlled phase III study, 218 postmenopausal women (age range, 42-74 y) were randomized to receive daily one of four DHEA concentrations intravaginally. Serum steroids were measured by a Good Laboratory Practice-validated mass spectrometry technology in samples obtained at time of visit. RESULTS:: The serum levels of DHEA and 11 of its metabolites measured at screening, day 1, and weeks 2, 4, 8, and 12 in women showed no or minimal changes during the whole observation period, with all values remaining well within the limits of normal postmenopausal women. No accumulation of the steroid metabolites nor change in DHEA bioavailability was detected. CONCLUSIONS:: The present data show that local daily intravaginal DHEA administration at DHEA doses of 3.25-13 mg was able to rapidly and efficiently achieve correction of all the signs and symptoms of vaginal atrophy and improve sexual function and caused no or minimal changes in serum sex steroid levels, which all remain within the normal postmenopausal range, thus avoiding the risks of all estrogen formulations.
PMID: 19436226 [PubMed - as supplied by publisher]
Menopause. 2009 May 8. [Epub ahead of print]
Intravaginal dehydroepiandrosterone (Prasterone), the physiological and a highly efficient treatment of vaginal atrophy.
Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J.
From the 1Laval University Hospital Research Center and Laval University, Quebec, Canada; 2Endoceutics Inc., Quebec City, QC, Canada;3Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA; 4Clinique de Recherche en Santé des Femmes, Quebec City, Canada; 5Diex Recherche Inc., Sherbrooke, QC, Canada; 6Rapid Medical Research Inc., Cleveland, OH;7Clinique Gynécologique, Shawinigan, Canada; 8Montreal Clinical Study Center, Montreal, Canada; 9Centre Hospitalier affilié Universitaire de Québec, Quebec City, Canada; 10McGill University Health Center, Royal Victoria Hospital, Montreal, QC, Canada; and 11Veristat Inc., Boston, MA.
OBJECTIVE:: Because the secretion of dehydroepiandrosterone (DHEA), the exclusive source of sex steroids in postmenopausal women, is already decreased by 60% and continues to decline at the time of menopause, the objective of this study was to examine the effect of intravaginal DHEA on the symptoms and signs of vaginal atrophy. METHODS:: This prospective, randomized, double-blind and placebo-controlled phase III clinical trial studied the effect of Prasterone (DHEA) applied locally in the vagina on the signs and symptoms of vaginal atrophy in 216 postmenopausal women. RESULTS:: All three doses (0.25%, 0.5%, and 1.0%) of DHEA ovules applied daily intravaginally induced a highly significant beneficial change in the percentage of vaginal parabasal and superficial cells and pH as well as in the most bothersome symptom at 2 weeks. At the standard 12-week time interval, 0.5% DHEA caused a 45.9 +/- 5.31 (P < 0.0001 vs placebo) decrease in the percentage of parabasal cells, a 6.8 +/- 1.29% (P < 0.0001) increase in superficial cells, a 1.3 +/- 0.13 unit (P < 0.0001) decrease in vaginal pH, and a 1.5 +/- 0.14 score unit (P < 0.0001) decrease in the severity of the most bothersome symptom. Similar changes were seen on vaginal secretions, color, epithelial surface thickness, and epithelial integrity. Comparable effects were observed at the 0.25% and 1.0% DHEA doses. CONCLUSIONS:: Local Prasterone, through local androgen and estrogen formation, causes a rapid and efficient reversal of all the symptoms and signs of vaginal atrophy with no or minimal changes in serum steroids, which remain well within the normal postmenopausal range. This approach avoids the fear of systemic effects common to all presently available estrogen formulations and adds a novel physiological androgenic component to therapy.
PMID: 19436225 [PubMed - as supplied by publisher
Menopause. 2009 May 8. [Epub ahead of print]
Serum steroid levels during 12-week intravaginal dehydroepiandrosterone administration.
Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté I, Labrie C, Lavoie L, Bérubé R, Bélanger P, Berger L, Gilbert L, Martel C, Balser J.
From the 1Laval University Hospital Research Center and Laval University, Quebec, Canada; 2Endoceutics Inc., Quebec City, QC, Canada; 3Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA; 4Clinique de Recherche en Santé des Femmes, Quebec City, Canada; 5Diex Recherche Inc., Sherbrooke, QC, Canada; 6Rapid Medical Research Inc.,Cleveland, OH; 7Clinique Gynécologique, Shawinigan, Canada; 8Montreal Clinical Study Center, Montreal, Canada; 9Centre Hospitalier Affilié Universitaire de Québec, Quebec City, Canada; 10McGill University Health Center, Royal Victoria Hospital, Montreal, QC, Canada; and 11Veristat Inc., Boston, MA.
OBJECTIVE:: Because a previous 1-week study has shown no or minimal changes in the serum levels of dehydroepiandrosterone (DHEA) and its metabolites after up to daily 1.8% (23.4 mg) intravaginal DHEA, the objective of the present study was to investigate the serum steroid levels during a 12-week daily intravaginal administration of 0%, 0.25%, 0.5%, and 1.0% DHEA (Prasterone) 1.3 mL ovules. METHODS:: In a double-blind, placebo-controlled phase III study, 218 postmenopausal women (age range, 42-74 y) were randomized to receive daily one of four DHEA concentrations intravaginally. Serum steroids were measured by a Good Laboratory Practice-validated mass spectrometry technology in samples obtained at time of visit. RESULTS:: The serum levels of DHEA and 11 of its metabolites measured at screening, day 1, and weeks 2, 4, 8, and 12 in women showed no or minimal changes during the whole observation period, with all values remaining well within the limits of normal postmenopausal women. No accumulation of the steroid metabolites nor change in DHEA bioavailability was detected. CONCLUSIONS:: The present data show that local daily intravaginal DHEA administration at DHEA doses of 3.25-13 mg was able to rapidly and efficiently achieve correction of all the signs and symptoms of vaginal atrophy and improve sexual function and caused no or minimal changes in serum sex steroid levels, which all remain within the normal postmenopausal range, thus avoiding the risks of all estrogen formulations.
PMID: 19436226 [PubMed - as supplied by publisher]
posted by Dr Frank Ervolino | 8:29 PM
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