title: Transcervical administration of polidocanol foam prevents pregnancy in female baboons.
abstract: Our objective was to conduct a pilot study to determine if transcervical administration of polidocanol foam (PF) with or without doxycycline or benzalkonium chloride (BZK) would prevent pregnancy in baboons.
  
  
  
  In study phase 1, adult cycling baboons underwent a hysterosalpingogram to evaluate tubal patency prior to transcervical infusion of 20 mL of 5% PF followed by 1 mL of saline containing 100 mg doxycycline (5%/doxy; n=5), 3% PF plus doxycycline (3%/doxy; n=4), 3% PF with 0.01% BZK (3%/BZK; n=4) or no additional treatment (control; n=9). Immediately following treatment, animals received intramuscular depot medroxyprogesterone acetate (DMPA, 2 mg/kg) to suppress cyclicity during healing and were then socially housed with males of proven fertility. The primary outcome was pregnancy within six cycles of resumption of menses (efficacy phase 1). During study phase 2, PF-treated females from study phase 1 contributed additional cycles (6-8) of exposure (efficacy phase 2), and 5 control females who had recovered from medical abortion (after study phase 1 pregnancy) were subsequently treated with 5% PF (with DMPA) and exposed to breeding (efficacy phase 1; n=3 six cycles, n=2 five cycles).
  
  
  
  All females resumed normal menstrual cycles and mating activity after DMPA. During efficacy phase 1, 7/9 (78%) control females became pregnant. In contrast, fewer pregnancies occurred in PF-treated females: 5% PF 0/5 (0%), 5%/doxy 1/5 (20%), 3%/doxy 1/4 (25%) and 3%/BZK 1/4 (25%). During efficacy phase 2, only one additional pregnancy occurred (3%/BZK).
  
  
  
  A single transcervical treatment with 5% PF prevented pregnancy in most baboons. Cotreatment with doxycycline or BZK did not improve results.
  
  
  
  Transcervical intrauterine administration of PF resulted in a high rate of tubal occlusion with prevention of pregnancy; refinements are needed to increase the contraceptive rate following a single treatment to near 100%.
authors.affiliation: Department of Obstetrics & Gynecology, Oregon Health & Science University (OHSU), Portland, OR; Division of Reproductive and Developmental Sciences, Oregon National Primate Research Center, Beaverton, OR. Electronic address: jensenje@ohsu.edu.
authors.forename: Jeffrey T
authors.initials: JT
authors.lastname: Jensen
authors.affiliation: Division of Reproductive and Developmental Sciences, Oregon National Primate Research Center, Beaverton, OR.
authors.forename: Carol
authors.initials: C
authors.lastname: Hanna
authors.affiliation: Division of Reproductive and Developmental Sciences, Oregon National Primate Research Center, Beaverton, OR.
authors.forename: Shan
authors.initials: S
authors.lastname: Yao
authors.affiliation: Division of Reproductive and Developmental Sciences, Oregon National Primate Research Center, Beaverton, OR.
authors.forename: Emily
authors.initials: E
authors.lastname: Thompson
authors.affiliation: Southwest National Primate Research Center, San Antonio, TX.
authors.forename: Cassondra
authors.initials: C
authors.lastname: Bauer
authors.affiliation: Department of Obstetrics & Gynecology, Oregon Health & Science University (OHSU), Portland, OR; Division of Reproductive and Developmental Sciences, Oregon National Primate Research Center, Beaverton, OR.
authors.forename: Ov D
authors.initials: OD
authors.lastname: Slayden
mesh_terms: D000818:Animals; D001548:Benzalkonium Compounds / Q000008:administration & dosage; D003267:Contraception / Q000379:methods; D003271:Contraceptive Agents, Female / Q000008:administration & dosage; D004318:Doxycycline / Q000008:administration & dosage; D005260:Female; D007047:Hysterosalpingography / Q000187:drug effects; D008297:Male; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage; D008597:Menstrual Cycle / Q000187:drug effects; D010215:Papio / Q000502:physiology*; D010865:Pilot Projects; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011247:Pregnancy; D018873:Pregnancy Rate; D011270:Pregnancy, Animal; D012597:Sclerosing Solutions / Q000008:administration & dosage*; D013246:Sterilization, Tubal / Q000379:methods*
chemical_list: D001548:Benzalkonium Compounds; D003271:Contraceptive Agents, Female; D012597:Sclerosing Solutions; D000077423:Polidocanol; D011092:Polyethylene Glycols; D017258:Medroxyprogesterone Acetate; D004318:Doxycycline
keywords: Female; Nonhuman primate; Nonsurgical; Permanent contraception; Polidocanol; Sterilization