Effects of Dehydroepiandrosterone Therapy on Pubic Hair Growth and Psychological Well-Being in Adolescent Girls and Young Women with Central Adrenal Insufficiency: A Double-Blind, Randomized, Placebo-Controlled Phase III Trial

Binder, Gerhard; Weber, Samantha R.; Ehrismann, M.; Zaiser, N.; Meisner, C. A.; Ranke, M. B.; Maier, L.; Wudy, Stefan A.; Hartmann, Michaela F.; Heinrich, U.; Bettendorf, Markus; Doerr, H. G.; Pfaeffle, Roland; Keller, E.

doi:10.1210/jc.2008-1982

Cited by 44 publications

(31 citation statements)

References 29 publications

(37 reference statements)

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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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“…DHEA/S is implicated in the development of human pubic hair (Binder et al 2009), sweat and sebaceous glands (Stewart et al 1992), and elements of the hair follicle, as well as the skin (Thiboutot et al 2003). DHEAS is also found in axillary sweat (Labows et al 1979).…”

Section: Social Signals Of Middle Childhoodmentioning

confidence: 99%

Adrenarche and Middle Childhood

Campbell

2011

Hum Nat

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Middle childhood, the period from 6 to 12 years of age, is defined socially by increasing autonomy and emotional regulation, somatically by the development of anatomical structures for subsistence, and endocrinologically by adrenarche, the adrenal production of dehydroepiandrosterone (DHEA). Here I suggest that DHEA plays a key role in the coordinated development of the brain and body beginning with middle childhood, via energetic allocation. I argue that with adrenarche, increasing levels of circulating DHEA act to down-regulate the release of glucose into circulation and hence limit the supply of glucose which is needed by the brain for synaptogenesis. Furthermore, I suggest the antioxidant properties of DHEA may be important in maintaining synaptic plasticity throughout middle childhood within slow-developing areas of the cortex, including the insula, thamalus, and anterior cingulate cortex. In addition, DHEA may play a role in the development of body odor as a reliable social signal of behavioral changes associated with middle childhood.

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“…Binder et al [19] reported that atrichia pubis vanishes and psychological well-being improves significantly by daily replacement with 25 mg DHEA orally in adolescent girls with central adrenal insufficiency.…”

Section: Introductionmentioning

confidence: 99%

Adrenarche and Puberty in Children with Classic Congenital Adrenal Hyperplasia due to 21-Hydroxylase Deficiency

Völkl¹,

Öhl²,

Rauh³

et al. 2011

Horm Res Paediatr

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There have been only a few studies on adrenarche in girls with classic congenital adrenal hyperplasia (CAH) showing that dehydroepiandrosterone sulfate (DHEAS) levels did not rise at the physiological age of adrenarche. Objective: Longitudinal analysis of serum DHEAS levels and Tanner stages in CAH children. Design: We studied 98 CAH patients (52 females), aged between 1 month and 18.0 years. All patients had genetically proven classic CAH and received steroid substitution therapy. Results: Serum DHEAS levels did not differ between CAH children and healthy children from the age of 1 year until 5–6 years. Beginning at the age of 7–8 years, there was a continuous but blunted increase in DHEAS levels in CAH boys and girls compared to healthy children. There was no correlation of DHEAS levels with the genotype, glucocorticoid dosage, auxological data, or quality of metabolic control. Pubarche (PH2) as well as gonadarche (G2) and thelarche (B2) occurred significantly earlier in CAH boys and girls than in the reference group, but timing of menarche was normal. Conclusions: Pubarche and adrenarche are dissociated in classic CAH: earlier pubarche, gonadarche and thelarche, respectively, in both sexes contrast with the absence of typical adrenarche.

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Effects of Dehydroepiandrosterone Therapy on Pubic Hair Growth and Psychological Well-Being in Adolescent Girls and Young Women with Central Adrenal Insufficiency: A Double-Blind, Randomized, Placebo-Controlled Phase III Trial

Abstract: In adolescent girls with central adrenal insufficiency, daily replacement with 25 mg DHEA orally is beneficial: atrichia pubis vanishes, and psychological well-being improves significantly.

Cited by 44 publications

References 29 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

Adrenarche and Middle Childhood

Adrenarche and Puberty in Children with Classic Congenital Adrenal Hyperplasia due to 21-Hydroxylase Deficiency

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