The safety of 52 weeks of oral DHEA therapy for postmenopausal women

Panjari, Mary; Bell, Robin Jean; Jane, Fiona; Adams, Jenny; Morrow, Corallee; Davis, Susan Ruth

doi:10.1016/j.maturitas.2009.03.020

Cited by 49 publications

(33 citation statements)

References 24 publications

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“…In this study, the daily co-administration of 50 mg DHEA did not give rise to safety concerns, as supported by data from the literature [54][55][56][57][58][59][60][61]. As demonstrated also in this study…”

Section: Accepted M Manuscriptsupporting

confidence: 88%

Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II. Clinical effects

Zimmerman¹,

Foidart²,

Pintiaux³

et al. 2015

Contraception

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Source of fundingThe study was financially supported by Pantarhei Bioscience Conflict of interestYZ is an employee of Pantarhei Bioscience (PRB), the company developing the Androgen RestoredContraceptive concept for contraception. JMF has no conflict of interest in the course of this study.AP shares expertise as a lecturer, member of advisory boards, and/or consultant, with Bayer, Amgen, Gedeon Richter and Teva/Theramex, without personal gain. JMM has nothing to declare. KC has nothing to declare. BF has received fees and grant support from the following companies (in alphabetic order); Andromed, Ardana, Euroscreen, Ferring, Genovum, Merck (MSD), Merck Serono, Organon, Ovascience, Pantharei Bioscience, PregLem, Schering, Schering Plough, Serono, Uteron Pharma, Watson Pharmaceuticals and Wyeth. HCB is the CEO and a shareholder of PRB.After publication of the paper, PRB will make the clinical study report available upon request. The authors alone are responsible for the content and the writing of the paper. Clinical Trial Registration Number: ISRCTN06414473A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPT AbstractObjectives: Combined oral contraceptives (COCs) decrease androgen levels, including testosterone (T), which may be associated with sexual dysfunction and mood complaints in some women. We have shown that co-administration of dehydroepiandrosterone (DHEA) to a drospirenone (DRSP) containing COC restored total T levels to baseline and free T levels by 47%. Here we describe the effects on sexual function, mood and quality of life of such an intervention. Study design:This was a randomized, double-blind, placebo-controlled study in 99 healthy COC starters. A COC containing 30 µg ethinylestradiol (EE) and 3 mg DRSP was used for 3 cycles, followed by 6 cycles of the same COC combined with 50 mg/day DHEA or placebo. There were no statistically significant differences between groups for the MSFQ and Q-LES-Q scores. DHEA co-administration resulted in an acceptable safety profile. DHEA negated the beneficial effect of the COC on acne according to the subjects' self-assessment. A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPTConclusions: Co-administration with DHEA did not result in consistent improvements in sexual function, mood and quality of life indicators in women taking EE/DRSP.Retrospectively, the 50 mg dose of DHEA may be too low for this COC.Implications A well-balanced judgment of the clinical consequences of normalizing androgens during COC use may require complete normalization of free T.

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Section: Accepted M Manuscriptsupporting

confidence: 88%

Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II. Clinical effects

Zimmerman¹,

Foidart²,

Pintiaux³

et al. 2015

Contraception

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“…30,79,81 Nevertheless, most interventional studies found no effect of DHEA replacement therapy on glucose tolerance and diabetes mellitus. 11,14,33,36,47,78,85,92 Animal studies have suggested a protective effect of DHEA against atherosclerosis. [93][94][95][96] Current opinion consensus supports a lipid profile independent mechanism mediating the anti-atherosclerotic effects of DHEA, 18,[93][94][95] partly through transformation to estrogens and testosterone.…”

Section: Cardiovascular Diseasementioning

confidence: 99%

A Review of Age-Related Dehydroepiandrosterone Decline and Its Association with Well-Known Geriatric Syndromes: Is Treatment Beneficial?

Samaras

Frangos³

et al. 2013

Rejuvenation Research

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Dehydroepiandrosterone (DHEA) and its sulfate ester are the most abundant steroids in humans. DHEA levels fall with age in men and women, reaching values sometimes as low as 10%-20% of those encountered in young individuals. This age-related decrease suggests an ''adrenopause'' phenomenon. Studies point toward several potential roles of DHEA, mainly through its hormonal end products, making this decline clinically relevant. Unfortunately, even if positive effects of DHEA on muscle, bone, cardiovascular disease, and sexual function seem rather robust, extremely few studies are large enough and/or long enough for conclusions regarding its effects on aging. Moreover, because it has been publically presented as a ''fountain of youth'' equivalent, overthe-counter preparations lacking pharmacokinetic and pharmacodynamic data are widely used worldwide. Conceptually, supplementing a pre-hormone is extremely interesting, because it would permit the human organism to adequately use it throughout long periods, increasing or decreasing end products according to his needs. Nevertheless, data on the safety profile of long-term DHEA supplementation are still lacking. In this article, we examine the potential relation between low DHEA levels and well-known age-related diseases, such as sarcopenia, osteoporosis, dementia, sexual disorders, and cardiovascular disease. We also review risks and benefits of existing protocols of DHEA supplementation.

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“…estrogen effects on the other targets are clearly evident and their central modulation is demonstrated by the significant decrease of gonadotropins during the treatment (38). Moreover Panjari et al study demonstrated the safety of one-year therapy with 50 mg/day dHeA on the endometrium too (41).…”

Section: Endocrine Effects Of Dhea Supplementationmentioning

confidence: 98%

DHEA: a natural steroid for the treatment of menopausal women

Genazzani¹

2014

giog

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The safety of 52 weeks of oral DHEA therapy for postmenopausal women

Cited by 49 publications

References 24 publications

Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II. Clinical effects

Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II. Clinical effects

A Review of Age-Related Dehydroepiandrosterone Decline and Its Association with Well-Known Geriatric Syndromes: Is Treatment Beneficial?

DHEA: a natural steroid for the treatment of menopausal women

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