Estrone [BSA]

Analysis of urinary estrone conjugates and pregnanediol-3-glucuronide were used to document ovarian events in female gorillas known to be fertile. These normal parameters were used to assess ovarian function in gorillas suspected as infertile. Insufficient luteal hormonal dynamics were observed in the infertile group. Based on this observation, exogenous progesterone as the only treatment was administered to infertile females post ovulation and mating. Positive pregnancy tests were observed in all 3 females during the progesterone treatment and one full-term pregnancy resulted. This successful treatment supports the concept that insufficient progesterone secretion may be a contributing factor to the infertility of captive female gorillas. The present data demonstrate the utility of urinary assays for evaluating ovarian function in gorillas and suggest that one type of infertility may be resolved with progesterone therapy.

This study integrates all data obtained in women aged 40-80 years enrolled with moderate to severe symptoms of vulvovaginal atrophy (VVA) who received daily intravaginal administration of 0.50% (6.5 mg) dehydroepiandrosterone (DHEA; prasterone) for 12 weeks (n= 723; ITT-S population) as compared with placebo (n=266; ITT-S population). To this end, serum steroid levels (DHEA, DHEA-sulfate (DHEA-S), androst-5-ene-3 beta, 17 beta-diol (5-diol), testosterone, dihydrotestosterone (DHT), androstenedione (4-dione), estrone (E-1), estradiol (E-2), estrone sulfate (E-1-S), androsterone glucuronide (ADT-G), and androstane-3 alpha, 17(beta-diol 17-glucuronide (3 alpha-diol-17G)) were measured at Day 1 and Week 12 by liquid chromatography-tandem mass spectrometry (LC-MS/MS) following validation performed according to the FDA guidelines [1-6]. In agreement with the mechanisms of intracrinology where DHEA is exclusively transformed intracellularly into active sex steroids which act and are inactivated locally before being released as glucuronided or sulfated metabolites for elimination by the kidneys and liver, all sex steroids remained well within normal postmenopausal values following administration of intravaginal DHEA. Serum, estradiol, the most relevant sex steroid, was measured after 12 weeks of treatment at 3.36 pg/ml(cITT-S population) or 19% below the normal postmenopausal value of 4.17 pg/ml. On the other hand, serum E-1-S, the best recognized marker of global estrogenic activity, shows an average value of 209 pg/ml at 12 weeks compared to 220 pg/ml in normal postmenopausal women. Moreover, serum ADT-G, the main metabolite of androgens, also remains well within normal postmenopausal values. The present data shows that a low daily intravaginal dose (6.5 mg) of DHEA (prasterone) which is efficacious on the symptoms and signs of VVA, permits to achieve the desired local efficacy without systemic exposure, in agreement with the stringent mechanisms of menopause established after 500 million years of evolution where each cell in each tissue is the master of its sex steroid exposure. (C) 2016 Elsevier Ltd. All rights reserved.