Gurmeet K S Singh1, Leo Turner, Reena Desai, Mark Jimenez, David J Handelsman. 1. Andrology Department (G.K.S.S., L.T., M.J., D.J.H.), Concord Hospital, Sydney, New South Wales 2139, Australia; Faculty of Pharmacy (G.K.S.S.), Universiti Teknologi MARA, Bandar Puncak Alam, Selangor, 42300 Malaysia; and ANZAC Research Institute (G.K.S.S., R.D., M.J., D.J.H.), University of Sydney, Sydney New South Wales 2139, Australia.
Abstract
CONTEXT: Testosterone (T) and nandrolone (N) esters require deep im injections by medical personnel but these often deposit injectate into sc fat so that more convenient sc self-administration may be feasible. OBJECTIVE: To investigate the feasibility and pharmacology of sc injection of N decanoate in healthy men using dried blood spot (DBS) for frequent blood sampling without clinic visits. SETTING AND DESIGN: Healthy male volunteers received 100 mg N decanoate by a single sc injection. Finger-prick capillary blood was spotted onto filter paper before injection daily at home for 21 d and stored at room temperature. Venous whole blood was also spotted onto filter paper before and weekly for 3 wk after injection. DBS were extracted for assay of N and T by liquid chromatography tandem mass spectrometry in a single batch with serum concentrations estimated with adjustment for capillary blood sample volume and hematocrit to define peak (N) or nadir (T) time and concentration from individual daily measurements. RESULTS: Daily serum N peaked 2.50 ± 0.25 (SEM) ng/mL at a median (range) of 6 (4-13) days causing a reduction in serum T from 3.50 ± 0.57 ng/mL at baseline to a nadir of 0.38 ± 0.13 (SEM) ng/mL (89 ± 3% suppression) at a median (range) of 8 (5-16) days. Simultaneously sampled capillary, venous whole blood, and serum gave almost identical results for serum T and N. Finger-pricks and sc injections were well tolerated. CONCLUSIONS: This study demonstrates that A) DBS sampling with liquid chromatography mass spectrometry steroid analysis achieves frequent time sampling in the community without requiring clinic visits, venesection, or frozen serum storage, and B) androgen esters in an oil vehicle can be delivered effectively by sc injection, thus avoiding the need for medically supervised deep-im injections.
CONTEXT: Testosterone (T) and nandrolone(N) esters require deep im injections by medical personnel but these often deposit injectate into sc fat so that more convenient sc self-administration may be feasible. OBJECTIVE: To investigate the feasibility and pharmacology of sc injection of N decanoate in healthy men using dried blood spot (DBS) for frequent blood sampling without clinic visits. SETTING AND DESIGN: Healthy male volunteers received 100 mg N decanoate by a single sc injection. Finger-prick capillary blood was spotted onto filter paper before injection daily at home for 21 d and stored at room temperature. Venous whole blood was also spotted onto filter paper before and weekly for 3 wk after injection. DBS were extracted for assay of N and T by liquid chromatography tandem mass spectrometry in a single batch with serum concentrations estimated with adjustment for capillary blood sample volume and hematocrit to define peak (N) or nadir (T) time and concentration from individual daily measurements. RESULTS: Daily serum N peaked 2.50 ± 0.25 (SEM) ng/mL at a median (range) of 6 (4-13) days causing a reduction in serum T from 3.50 ± 0.57 ng/mL at baseline to a nadir of 0.38 ± 0.13 (SEM) ng/mL (89 ± 3% suppression) at a median (range) of 8 (5-16) days. Simultaneously sampled capillary, venous whole blood, and serum gave almost identical results for serum T and N. Finger-pricks and sc injections were well tolerated. CONCLUSIONS: This study demonstrates that A) DBS sampling with liquid chromatography mass spectrometry steroid analysis achieves frequent time sampling in the community without requiring clinic visits, venesection, or frozen serum storage, and B) androgen esters in an oil vehicle can be delivered effectively by sc injection, thus avoiding the need for medically supervised deep-im injections.
Authors: Maria Almeida; Michaël R Laurent; Vanessa Dubois; Frank Claessens; Charles A O'Brien; Roger Bouillon; Dirk Vanderschueren; Stavros C Manolagas Journal: Physiol Rev Date: 2017-01 Impact factor: 37.312
Authors: Leo Turner; Lam P Ly; Reena Desai; Gurmeet K S Singh; Timothy D Handelsman; Sasha Savkovic; Carolyn Fennell; Veena Jayadev; Ann Conway; David J Handelsman Journal: J Endocr Soc Date: 2019-06-28
Authors: Astrid M H Horstman; Evelien M P Backx; Joey S J Smeets; Gabriel N Marzuca-Nassr; Janneau van Kranenburg; Douwe de Boer; John Dolmans; Tim Snijders; Lex B Verdijk; Lisette C P G M de Groot; Luc J C van Loon Journal: PLoS One Date: 2019-01-28 Impact factor: 3.240