| Effect of sexual intercourse on the absorption of levonorgestrel after vaginal administration of 0.75 mg in Carraguard gel: a randomized, cross-over, pharmacokinetic study. | |
| | |
MedLine Citation:
|
PMID: 19135574 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
BACKGROUND: The Population Council studied a pre-coital contraceptive microbicide vaginal product containing levonorgestrel (LNG) as active component and Carraguard gel as a vehicle (Carra/LNG gel) for couples who engage in occasional unplanned intercourse. The objective of this study was to evaluate the effect of sexual intercourse after vaginal application of Carra/LNG gel on serum levels of LNG in women and to assess LNG absorption by the male partner. STUDY DESIGN: This was a randomized, cross-over, pharmacokinetic study including an abstinence arm and an arm in which couples engaged in sexual intercourse between 2 and 4 h after gel application. In each study arm, each woman received a single application of Carra/LNG gel (0.75 mg in 4 mL gel) followed by serial blood samples taken at 0, 1, 2, 4, 8, 24 and 48 h after gel application for LNG measurements. In the intercourse arm, LNG was measured in blood samples taken from the male partner before intercourse and at 4, 8 and 24 h after gel application in the female partner. RESULTS: Time concentration curves for serum LNG levels showed a mean C(max) of 7.8+/-5.5 and 8.3+/-5.7 nmol/L, a mean T(max) of 6.2+/-5.9 and 7.5+/-5.7, and comparable area under the curve for the intercourse and abstinence arm, respectively. Pharmacokinetic parameters presented large variability between subjects, but excellent reproducibility within each subject. LNG was undetectable in 10 out of 12 male partners. CONCLUSION: Sexual intercourse does not appear to interfere with vaginal absorption of LNG after application of a Carra/LNG gel. A vaginal pre-coital contraceptive gel is feasible. |
| | |
Authors:
|
Vivian Brache; Horacio Croxatto; Narender Kumar; Regine Sitruk-Ware; Leila Cochón; Veronica Schiappacasse; Irving Sivin; Carla Muñoz; Robin Maguire; Anibal Faundes |
Related Documents
:
|
21175844 - Engaging the recreational angling community to implement and manage aquatic protected a... 5312994 - Study on vibrio cholerae infection in a small community in calcutta. joint icmr-gwb-who... 22388984 - Comment on "dynamic factors in the reactions between the magic cluster al(13)(-) and hc... 22499624 - A decision theory approach to the approximation of discrete probability densities. 8668904 - Hearing aid systems in undeveloped, developed and industrialized countries. 22042974 - Reg-γ associates with and modulates the abundance of nuclear activation-induced deamin... |
Publication Detail:
|
Type: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural Date: 2008-11-21 |
Journal Detail:
|
Title: Contraception Volume: 79 ISSN: 1879-0518 ISO Abbreviation: Contraception Publication Date: 2009 Feb |
Date Detail:
|
Created Date: 2009-01-12 Completed Date: 2009-04-09 Revised Date: 2011-02-17 |
Medline Journal Info:
|
Nlm Unique ID: 0234361 Medline TA: Contraception Country: United States |
Other Details:
|
Languages: eng Pagination: 150-4 Citation Subset: IM |
Affiliation:
|
PROFAMILIA, Santo Domingo, Dominican Republic. biomedica@codetel.net.do |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Absorption Administration, Intravaginal Adult Carrageenan / administration & dosage, blood, pharmacokinetics* Coitus / physiology* Contraceptive Agents, Female / administration & dosage, blood, pharmacokinetics* Cross-Over Studies Female Humans Levonorgestrel / administration & dosage, blood, pharmacokinetics* Male Middle Aged Vaginal Creams, Foams, and Jellies / administration & dosage, pharmacokinetics* |
| Grant Support | |
ID/Acronym/Agency:
|
U54 HD 29990/HD/NICHD NIH HHS; U54 HD029990-18/HD/NICHD NIH HHS |
| Chemical | |
Reg. No./Substance:
|
0/Contraceptive Agents, Female; 0/Vaginal Creams, Foams, and Jellies; 797-63-7/Levonorgestrel; 9000-07-1/Carrageenan |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Sexual activity and contraceptive use among young female students of tertiary educational institutio...
Next Document: Ectopic pregnancy following levonorgestrel emergency contraception: a case report.