Prenatal Virilization Associated with Paternal Testosterone Gel Therapy

Patel, Anisha; Rivkees, Scott A.

doi:10.1155/2010/867471

Cited by 9 publications

(16 citation statements)

References 11 publications

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“…Publications identified were on methotrexate [22], lamuvidine [23], thiopurines [2,24] such as mercaptopurine [25] and azathioprine, ribavirin [26] and the combination of ribavirin--IFNa B2 combination [27], antirheumatics [18] such as methotrexate, sulfasalazin and biologics, finasteride [28], paroxetine [5] and testosterone gel [29]. The results of these studies are often contradictive.…”

Section: Discussionmentioning

confidence: 99%

Paternal drug use: before and during pregnancy

Crijns

Bos

Knol

et al. 2012

Expert Opinion on Drug Safety

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Section: Discussionmentioning

confidence: 99%

Paternal drug use: before and during pregnancy

Crijns

Bos

Knol

et al. 2012

Expert Opinion on Drug Safety

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“…Testosterone gels can overcome some of the said problems if men apply the gel correctly and are compliant with daily application. There are concerns with cross contamination of partners or children . The new use of enclomiphene citrate has been described to a considerable extent .…”

Section: Introductionmentioning

confidence: 99%

Oral Enclomiphene Citrate Stimulates the Endogenous Production of Testosterone and Sperm Counts in Men with Low Testosterone: Comparison with Testosterone Gel

Kaminetsky

Werner

Fontenot

et al. 2013

The Journal of Sexual Medicine

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Introduction Clomiphene citrate is employed off-label in men who have low testosterone and for the restoration of sperm counts in men who have used exogenous testosterone. Clomiphene is a mixture of two diastereoisomers: zuclomiphene and enclomiphene. We evaluated enclomiphene citrate in men with secondary hypogonadism. Aim Our aim was to compare oral enclomiphene citrate as an alternative to topical testosterone. Main Outcome Measures Blood levels of total testosterone (TT), estradiol, follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone binding globulin, thyroid stimulation hormone, prolactin, and insulin-like growth factor 1 IGF-1 were measured at certain times after treatment with each agent. Sperm parameters were determined at the same visits. Free testosterone (FT) was calculated. Methods This was a proof-of-principle, randomized, open-label, fixed dose, active-control, two-center phase IIB study in 12 men with secondary hypogonadism treated previously with topical testosterone. Results After discontinuation of topical testosterone, morning TT values averaged 165 ± 66 pg/dL. After 3 months, there was a significant rise in men receiving enclomiphene citrate and gel that was sustained for 3 months. At 6 months, TT levels were 545 ± 268 and 525 ± 256 pg/dL for groups receiving the gel and enclomiphene citrate, respectively. Only men in the enclomiphene citrate group demonstrated increased LH and FSH. TT decreased one month posttreatment to pretreatment values. Enclomiphene citrate elevated sperm counts in seven out of seven men at 3 months and six out of six men at 6 months with sperm concentrations in the 75–334 × 106/mL range. The gel was ineffective in raising sperm counts above 20 × 106/mL for all five men at 3 months and raised counts in only two or five men at 6 months. At follow-up, only enclomiphene citrate treatment was associated with elevated sperm counts. Conclusions Enclomiphene citrate increased testosterone and sperm counts. Concomitant changes in LH and FSH suggest normalization of endogenous testosterone production and restoration of sperm counts through the hypothalamic–pituitary–testicular axis.

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“…Despite knowledge of this phenomenon, little is known regarding the sensitivity of the female larynx to androgen exposure during the pre-pubertal stage. This knowledge gap is primarily due to the absence of F0 analysis not only in the rare cases of childhood ACT [15], [16], but also in the few cases of childhood virilization caused by topical exposure (usually accidental) to testosterone in the form of gels or patches [29]–[31]. To our knowledge, this study is the first long-term analysis of F0 in female patients exposed to high levels of androgens at a very young age.…”

Section: Discussionmentioning

confidence: 95%

Impact of Early Postnatal Androgen Exposure on Voice Development

Grisa

Leonel²,

Gonçalves

et al. 2012

PLoS ONE

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BackgroundThe impact of early postnatal androgen exposure on female laryngeal tissue may depend on certain characteristics of this exposure. We assessed the impact of the dose, duration, and timing of early androgen exposure on the vocal development of female subjects who had been treated for adrenocortical tumor (ACT) in childhood.MethodsThe long-term effects of androgen exposure on the fundamental vocal frequency (F0), vocal pitch, and final height and the presence of virilizing signs were examined in 9 adult (age, 18.4 to 33.5 years) and 10 adolescent (13.6 to 17.8 years) female ACT patients. We also compared the current values with values obtained 0.9 years to 7.4 years after these subjects had undergone ACT surgery, a period during which they had shown normal androgen levels.ResultsOf the 19 subjects, 17 (89%) had been diagnosed with ACT before 4 years of age, 1 (5%) at 8.16 years, and 1 (5%) at 10.75 years. Androgen exposure (2 to 30 months) was sufficiently strong to cause pubic hair growth in all subjects and clitoromegaly in 74% (14/19) of the subjects, but did not reduce their height from the target value. Although androgen exposure induced a remarkable reduction in F0 (132 Hz) and moderate pitch virilization in 1 subject and partial F0 virilization, resulting in F0 of 165 and 169 Hz, in 2 subjects, the majority had normal F0 ranging from 189 to 245 Hz.ConclusionsFemale laryngeal tissue is less sensitive to androgen exposure between birth and adrenarche than during other periods. Differential larynx sensitivity to androgen exposure in childhood and F0 irreversibility in adulthood are age-, concentration-, duration-, and timing-dependent events that may also be affected by exposure to inhibitory or stimulatory hormones. Further studies are required to better characterize each of these factors.

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Prenatal Virilization Associated with Paternal Testosterone Gel Therapy

Cited by 9 publications

References 11 publications

Paternal drug use: before and during pregnancy

Paternal drug use: before and during pregnancy

Oral Enclomiphene Citrate Stimulates the Endogenous Production of Testosterone and Sperm Counts in Men with Low Testosterone: Comparison with Testosterone Gel

Impact of Early Postnatal Androgen Exposure on Voice Development

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