Sexual absorption of vaginal progesterone: a randomized control trial

Kathryn S Merriam, Kristina A Leake, Mollie Elliot, Michelle L Matthews, Rebecca S Usadi, Bradley S Hurst, Kathryn S Merriam, Kristina A Leake, Mollie Elliot, Michelle L Matthews, Rebecca S Usadi, Bradley S Hurst

Abstract

Objective. To determine if sexual intercourse reduces absorption of vaginal progesterone gel in women and to determine if progesterone is absorbed by the male during intercourse. Study Design. Prospective, randomized, cross over, controlled study of 20 reproductive-aged women and their male sexual partners randomized to receive vaginal progesterone gel (Crinone 8% gel, Actavis Inc., USA) or placebo cream. Serum progesterone for both male and female partners were measured 10 hours after intercourse. One week later, subjects were crossed over to receive the opposite formulation. In the third week, women used progesterone gel at night and abstained from intercourse. Results. Serum progesterone was significantly reduced with vaginal progesterone gel + intercourse compared with vaginal progesterone gel + abstinence (P = 0.0075). Men absorbed significant progesterone during intercourse with a female partner using vaginal progesterone gel compared to placebo (P = 0.0008). Conclusion(s). Vaginal progesterone gel is reduced in women after intercourse which may decrease drug efficacy during luteal phase support. Because men absorb low levels of progesterone during intercourse, exposure could cause adverse effects such as decreased libido. This study is registered under Clinical Trial number NCT01959464.

Figures

Figure 1
Figure 1
Study methods.
Figure 2
Figure 2
Distribution of female serum progesterone by treatment group. Crinone and abstinence group: maximum 11.9, minimum 3.5, and average 7.042. Crinone and intercourse group: maximum 10.7, minimum 0.9, and average 4.021. Placebo and intercourse group: maximum 2.1, minimum 0.2, and average 0.842.
Figure 3
Figure 3
Distribution of male serum progesterone by treatment group. Crinone group: maximum 1.8, minimum 0.2, and average 0.853. Placebo group: maximum 1, minimum 0.3, and average 0.584.

References

    1. Daya S., Gunby J. Luteal phase support in assisted reproduction cycles. Cochrane Database of Systematic Reviews. 2004;(3)CD004830
    1. Yanushpolsky E., Hurwitz S., Greenberg L., Racowsky C., Hornstein M. Crinone vaginal gel is equally effective and better tolerated than intramuscular progesterone for luteal phase support in in vitro fertilization-embryo transfer cycles: a prospective randomized study. Fertility and Sterility. 2010;94(7):2596–2599. doi: 10.1016/j.fertnstert.2010.02.033.
    1. Polyzos N. P., Messini C. I., Papanikolaou E. G., et al. Vaginal progesterone gel for luteal phase support in IVF/ICSI cycles: a meta-analysis. Fertility and Sterility. 2010;94(6):2083–2087. doi: 10.1016/j.fertnstert.2009.12.058.
    1. Fonseca E. B., Celik E., Parra M., Singh M., Nicolaides K. H. Progesterone and the risk of preterm birth among women with a short cervix. The New England Journal of Medicine. 2007;357(5):462–469. doi: 10.1056/nejmoa067815.
    1. Cooper A. J. Progestogens in the treatment of male sex offenders: a review. Canadian Journal of Psychiatry. 1986;31(1):73–79.
    1. Cooper A. J., Sandhu S., Losztyn S., Cernovsky Z. A double-blind placebo controlled trial of medroxyprogesterone acetate and cyproterone acetate with seven pedophiles. Canadian Journal of Psychiatry. 1992;37(10):687–693.
    1. Money J. Treatment guidelines: antiandrogen and counseling of paraphilic sex offenders. Journal of Sex and Marital Therapy. 1987;13(3):219–223.
    1. Hurst B. S., Jones A. I., Elliot M., Marshburn P. B., Matthews M. L. Absorption of vaginal estrogen cream during sexual intercourse: a prospective, randomized, controlled trial. Journal of Reproductive Medicine for the Obstetrician and Gynecologist. 2008;53(1):29–32.
    1. Actavis. Prescribing Information for Crinone. February 2014, .
    1. Mircette Prescribing Information. .
    1. ASRM Practice Committee. Progesterone supplementation during the luteal phase and in early pregnancy in the treatment of infertility: an educational bulletin. ASRM Practice Committee Position Statement. Fertility and Sterility. 2008;90:S150–S153.
    1. ASRM Practice Committee. The clinical relevance of luteal phase deficiency: a committee opinion. ASRM Practice Committee Position Statement. Fertility and Sterility. 2008;98:1112–1117.
    1. Miles R. A., Paulson R. J., Lobo R. A., Press M. F., Dahmoush L., Sauer M. V. Pharmacokinetics and endometrial tissue levels of progesterone after administration by intramuscular and vaginal routes: a comparative study. Fertility and Sterility. 1994;62(3):485–490.
    1. De Ziegler D., Bulletti C., de Monstier B., Jääskeläinen A.-S. The first uterine pass effect. Annals of the New York Academy of Sciences. 1997;828:291–299. doi: 10.1111/j.1749-6632.1997.tb48550.x.
    1. Levy T., Yairi Y., Bar-Hava I., Shalev J., Orvieto R., Ben-Rafael Z. Pharmacokinetics of the progesterone-containing vaginal tablet and its use in assisted reproduction. Steroids. 2000;65(10-11):645–649. doi: 10.1016/S0039-128X(00)00121-5.
    1. Crochet J. R., Peavey M. C., Price T. M., Behera M. A. Spontaneous pregnancy reaches viability after low first trimester serum progesterone: a case report. Journal of Reproductive Medicine. 2012;57(3-4):171–174.
    1. Cicinelli E., de Ziegler D., Bulletti C., Matteo M. G., Schonauer L. M., Galantino P. Direct transport of progesterone from vagina to uterus. Obstetrics and Gynecology. 2000;95(3):403–406. doi: 10.1016/s0029-7844(99)00542-6.

Source: PubMed

3
S'abonner