TITLE

Safety and pharmacokinetic study with escalating doses of 3-acetyl-7-oxo-dehydroepiandrosterone in healthy male volunteers

AUTHOR(S)
Davidson, Michael; Marwah, Ashok; Sawchuk, Ronald J.; Maki, Kevin; Marwah, Padma; Weeks, Charles; Lardy, Henry; Davidson, M; Marwah, A; Sawchuk, R J; Maki, K; Marwah, P; Weeks, C; Lardy, H
PUB. DATE
October 2000
SOURCE
Clinical & Investigative Medicine;Oct2000, Vol. 23 Issue 5, p300
SOURCE TYPE
Academic Journal
DOC. TYPE
journal article
ABSTRACT
Objectives: To evaluate the safety and pharmacokinetics of 3-acetyl-7-oxo-DHEA (3beta-acetoxyandrost-5-ene-7,17-dione) given orally.Design: A randomized, double blind, placebo-controlled, escalating dose study.Setting: The Chicago Center for Clinical Research.Participants: Twenty-two healthy men.Study Method: The participants received placebo (n = 6) or 3-acetyl-7-oxo-DHEA (n = 16) at 50 mg/d for 7 days followed by a 7-day washout; 100 mg/d for 7 days followed by a 7-day washout; and 200 mg/d for 28 days.Outcome Measures: Safety parameters, evaluated at each dose level, included measurement of total testosterone, free testosterone, dihydrotestosterone, estradiol, cortisol, thyroxin and insulin levels. Analyses for 7-oxo-DHEA-3beta-sulfate (DHEA-S), the only detectable metabolic product of the administered steroid, were conducted on plasma drawn from all subjects at 0.25, 0.5, 1, 2, 4, 6 and 12 hours after the final 100 mg dose of 3beta-acetyl-7-oxo-DHEA.Results: There were no differences in the clinical laboratory values or in reported minor adverse experiences, between treatment and placebo groups. In general, blood hormone concentrations were unaffected by the treatment with 3beta-acetyl-7-oxo-DHEA and remained within the normal range. No changes in vital signs, blood chemistry or urinalysis occurred during treatment with 3beta-acetyl-7-oxo-DHEA compared to placebo. The administered steroid was not detected in the blood but was rapidly converted to 7-oxo-DHEA-S, the concentrations of which were proportional to dose. This steroid sulfate did not accumulate; plasma concentrations 12 hours after the 3beta-acetyl-7-oxo-DHEA dose at 7 and 28 days on the 200 mg/d dose were 15.8 and 16.3 microg/L respectively. The mean time to peak plasma level of 7-oxo-DHEA-S was 2.2 hours; the mean half life was 2.17 hours. The apparent clearance averaged 172 L/h, and the apparent mean volume of distribution was 540 L.Conclusion: These results indicate that 3beta-acetyl-7-oxo-DHEA is safe and well tolerated in normal healthy men at doses up to 200 mg/d for 4 weeks. INSET: Metabolic functions of 7-oxo-dehydroepiandrosterone.
ACCESSION #
3716697

 

Related Articles

  • Intravaginal gel prepared from Dead Sea peloid for treating luteal-phase defect Artymuk, Natalia V.; Kira, Eugeniy F.; Kondratieva, Tatiana A. // International Journal of Gynecology & Obstetrics;Jan2010, Vol. 108 Issue 1, p72 

    No abstract available.

  • Better than sham? A double-blind placebo-controlled neurofeedback study in primary insomnia. Schabus, Manuel; Griessenberger, Hermann; Gnjezda, Maria-Teresa; Heib, Dominik P. J.; Wislowska, Malgorzata; Hoedlmoser, Kerstin // Brain: A Journal of Neurology;Apr2017, Vol. 140 Issue 4, p1041 

    See Thibault et al. (doi:10.1093/awx033) for a scientific commentary on this article.Neurofeedback training builds upon the simple concept of instrumental conditioning, i.e. behaviour that is rewarded is more likely to reoccur, an effect Thorndike referred to as the 'law of effect'. In the case...

  • Randomized, Double-Blind Evaluation of Late Boost Strategies for HIV-Uninfected Vaccine Recipients in the RV144 HIV Vaccine Efficacy Trial. Rerks-Ngarm, Supachai; Pitisuttithum, Punnee; Excler, Jean-Louis; Nitayaphan, Sorachai; Kaewkungwal, Jaranit; Premsri, Nakorn; Kunasol, Prayura; Karasavvas, Nicos; Schuetz, Alexandra; Ngauy, Viseth; Sinangil, Faruk; Dawson, Peter; deCamp, Allan C.; Phogat, Sanjay; Garunathan, Sanjay; Tartaglia, James; DiazGranados, Carlos; Ratto-Kim, Silvia; Pegu, Poonam; Eller, Michael // Journal of Infectious Diseases;4/15/2017, Vol. 215 Issue 8, p1255 

    Background: The RV144 ALVAC-HIV prime, AIDSVAX B/E boost afforded 60% efficacy against human immunodeficiency virus (HIV) acquisition at 1 year, waning to 31.2% after 3.5 years. We hypothesized that additional vaccinations might augment immune correlates of protection.Methods:...

  • The effect of sodium valproate on tardive dyskinesia--revisited. Fisk, G.G.; York, S.M. // British Journal of Psychiatry;Apr87, Vol. 150, p542 

    As a treatment for tardive dyskinesia, sodium valproate was tested in a double-blind placebo-controlled parallel group trial, with 6-week base-line observation period followed by 6 weeks of treatment. Sodium valproate was not found to be an effective treatment for either tardive dyskinesia or...

  • Misoprostol Prior to Diagnostic Office Hysteroscopy in the Subgroup of Patients with No Risk Factors for Cervical Stenosis: A Randomized Double Blind Placebo-Controlled Trial. Fouda, Usama M.; Elsetohy, Khaled A.; Elshaer, Hesham S.; Hammad, Bahaa Eldin M.; Shaban, Mona M.; Youssef, Mohamed A.; Hashem, Ahmed T.; Attia, Ahmed H. // Gynecologic & Obstetric Investigation;Sep2018, Vol. 83 Issue 5, p455 

    Aims: To assess the effectiveness of vaginal misoprostol in minimizing the pain perceived by patients with no risk factors for cervical stenosis (i.e., parous women of reproductive age who have no history of cesarean section or cervical surgery) during diagnostic office...

  • Lithium in the treatment of aggression in mentally handicapped patients. A double-blind trial. Craft, M.; Ismail, I. A.; Krishnamurti, D.; Mathews, J.; Regan, A.; Seth, R. V.; North, P. M. // British Journal of Psychiatry;May87, Vol. 150, p685 

    In a double-blind trial lasting 4 months in 42 mentally handicapped patients, the effect of lithium on aggression was assessed in comparison with placebo. In the lithium-treated group, 73% of patients showed a reduction in aggression during treatment. There were significant differences in mean...

  • A double-blind placebo-controlled study of buspirone in diazepam withdrawal in chronic benzodiazepine users. Ashton, C.H.; Rawlings, M.D.; Tyrer, S.P.; Rawlins, M D // British Journal of Psychiatry;Aug90, Vol. 157, p232 

    A double-blind placebo-controlled trial of 23 chronic benzodiazepine users showed that overall, buspirone did not appear to be helpful in alleviating benzodiazepine withdrawal symptoms. Buspirone (5 mg t.d.s.) or placebo was administered for four weeks before, during and after diazepam...

  • Acute blocking of naloxone-precipitated opiate withdrawal symptoms by methohexitone. Loimer, N.; Schmid, R.; Lenz, K.; Presslich, O.; Gr├╝nberger, J.; Gr├╝nberger, J // British Journal of Psychiatry;Nov90, Vol. 157, p748 

    In a double-blind placebo-controlled trial of 18 patients, methohexitone blocked objective signs of opiate withdrawal caused by a bolus injection of naloxone. Furthermore, in continuing the naloxone therapy for 48 hours, no withdrawal signs appeared. Levels of withdrawal distress returned to...

  • The use of low-dose IV haloperidol is not associated with QTc prolongation: post hoc analysis of a randomized, placebo-controlled trial. Duprey, Matthew; Al-Qadheeb, Nada; Roberts, Russel; Skrobik, Yoanna; Schumaker, Greg; Devlin, John; Duprey, Matthew S; Devlin, John W // Intensive Care Medicine;Nov2016, Vol. 42 Issue 11, p1818 

    A letter to the editor is presented in response to the article "The use of low-dose IV haloperidol is not associated with QTc prolongation: post hoc analysis of a randomized, placebo controlled trial" in the September 16, 2016 issue.

  • Drotaverine hydrochloride for augmentation of labor Singh, K.C.; Jain, P.; Goel, N.; Saxena, A. // International Journal of Gynecology & Obstetrics;Jan2004, Vol. 84 Issue 1, p17 

    Objectives: To study the use of drotaverine hydrochloride for acceleration of labor and relief of labor pains. Methods: In this double-blind placebo-controlled randomized study, 100 primigravidas in uncomplicated spontaneous labor at term were given drotaverine hydrochloride or placebo...

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics