Dimethandrolone (DMA, 7α,11β-dimethyl-19-nortestosterone) has both androgenic and progestational activities, ideal properties for a male hormonal contraceptive. In vivo, dimethandrolone undecanoate (DMAU) is hydrolyzed to DMA. We showed previously that single oral doses of DMAU powder-in-capsule taken with food are well-tolerated and effective at suppressing both LH and testosterone (T), but absorption was low. We compared the pharmacokinetics and pharmacodynamics of two new formulations of DMAU, in castor oil and in SEDDS, with the previously tested powder formulation. DMAU was dosed orally in healthy adult male volunteers at two academic medical centers. For each formulation tested in this double-blind, placebo-controlled study, ten men received single, escalating, oral doses of DMAU (100 mg, 200 mg, and 400 mg) and two subjects received placebo. All doses were evaluated both fasting and with a high fat meal. All three formulations were well tolerated without clinically significant changes in vital signs, blood counts, or serum chemistries. For all formulations, DMA and DMAU showed higher maximum (p< 0.007) and average concentrations (p<0.002) at the 400mg dose, compared with the 200mg dose. The powder formulation resulted in a lower conversion of DMAU to DMA (p=0.027) compared with both castor oil and SEDDS formulations. DMAU in SEDDS given fasting resulted in higher serum DMA and DMAU concentrations compared to the other two formulations. Serum LH and sex hormone concentrations were suppressed by all formulations of 200 and 400mg DMAU when administered with food but only the SEDDS formulation was effectively suppressed serum T when given fasting. We conclude that while all three formulations of oral DMAU are effective and well-tolerated when administered with food, DMAU in oil and SEDDS increased conversion to DMA, and SEDDS may have some effectiveness when given fasting. These properties might be advantageous for the application of DMAU as a male contraceptive.
Introduction We present a case of small bowel intussusception occurring in a female who had previously undergone Laparoscopic RYGB. Few case reports of retrograde intussusception occurring in pregnant patients with a history of LRYBG have been published. Up to our knowledge, this is the first case of this rare complication presenting in the postnatal period. Case report Our patient, a female in her thirties, gave birth to a healthy baby via caesarian section six years after her LRYGB. On the day following her operation, she experienced epigastric severe, progressive abdominal pain associated with nausea and vomiting. Abdominal examination showed epigastric and left upper quadrant tenderness, hypoactive bowel sounds and no palpable masses. Small bowel obstruction was suspected. A nasogastric tube was inserted and an abdominal CT scan with oral contrast was ordered. The CT scan showed multiple concentric segments of small bowel loops representing the intussusceptum pulled into the intussuscipiens, giving the classic doughnut sign. The patient was subsequently taken to theatre for a laparotomy. The mass was comprised of the biliopancreatic limb which was dilated as the common limb was retrogradely intussuscepting into it. The bowel was ischemic and remained so after manual reduction. A 45cm ischemic segment was resected and then primary re-anastomosis was done. Her postoperative course was unremarkable. Discussion Intussusception can present years after the original surgery, and imaging is not always reliable. Seeing as bariatric surgery is getting more popular, physicians should be well aware of this serious complication as delay in diagnosis increases morbidity and mortality.
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