Sexual Absorption of Vaginal Progesterone

Infertility Clinical Trial

Official title:

Sexual Absorption of Vaginal Progesterone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959464
• Other study ID #: SAVP2013
• Status: Completed
• Phase: Phase 4
• Start date: November 2008
• Est. completion date: September 2010

Study information

• Verified date: July 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if sexual intercourse lowers serum progesterone in women using vaginal progesterone gel (Crinone®), and increases serum progesterone in their male sexual partners. We hypothesize, based on previous estrogen studies done by our group, that intercourse will interfere with absorption of vaginal progesterone.

Description:

The effects of intercourse on the absorption of vaginal progesterone for the female user and her sexual partner have not been studied. However, a previous study performed by our group found that intercourse lowered the absorption of vaginal estrogen cream in women, and men absorbed a small but statistically significant amount of estradiol during intercourse. Vaginal progesterone gel may be used by women for several clinical indications, and if intercourse alters the absorption and distribution of vaginal progesterone, clinical outcomes may be compromised. If intercourse lowers absorption, the efficacy of the treatment could be reduced. If intercourse enhances absorption, side effects may be increased. Also, if the male sexual partner absorbs vaginal progesterone, undesirable side effects may occur.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Sexually active 18-40 year old heterosexual couple

• Subject willing to take Mircette birth control pills for at least one cycle (one pack)

• Willing to have intercourse at the defined times (at least weekly within a 3 week interval, and draw blood within 10 hours of intercourse)

• IRB signed informed consent

Exclusion Criteria:

• Undiagnosed vaginal bleeding

• Contraindication to oral contraceptives

• Liver dysfunction or disease

• Known sensitivity to Crinone

• Known or suspected malignancy of the breast or genital organs

• History of or active thrombophlebitis or thromboembolic disorders

• Use of condoms during intercourse

• Male erectile or ejaculatory dysfunction

Related Conditions & MeSH terms

• Infertility
• Pregnancy

Intervention

Drug:
• Crinone vaginal progesterone gel
Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator.
• Placebo vaginal gel
Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator.

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Carolinas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (13)

Cooper AJ, Sandhu S, Losztyn S, Cernovsky Z. A double-blind placebo controlled trial of medroxyprogesterone acetate and cyproterone acetate with seven pedophiles. Can J Psychiatry. 1992 Dec;37(10):687-93. — View Citation

Cooper AJ. Progestogens in the treatment of male sex offenders: a review. Can J Psychiatry. 1986 Feb;31(1):73-9. — View Citation

Daya S, Gunby J. Luteal phase support in assisted reproduction cycles. Cochrane Database Syst Rev. 2004;(3):CD004830. Review. Update in: Cochrane Database Syst Rev. 2008;(3):CD004830. — View Citation

De Ziegler D, Bulletti C, De Monstier B, Jääskeläinen AS. The first uterine pass effect. Ann N Y Acad Sci. 1997 Sep 26;828:291-9. Review. — View Citation

Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9. — View Citation

Hurst BS, Jones AI, Elliot M, Marshburn PB, Matthews ML. Absorption of vaginal estrogen cream during sexual intercourse: a prospective, randomized, controlled trial. J Reprod Med. 2008 Jan;53(1):29-32. — View Citation

Miles RA, Paulson RJ, Lobo RA, Press MF, Dahmoush L, Sauer MV. Pharmacokinetics and endometrial tissue levels of progesterone after administration by intramuscular and vaginal routes: a comparative study. Fertil Steril. 1994 Sep;62(3):485-90. — View Citation

Money J. Treatment guidelines: antiandrogen and counseling of paraphilic sex offenders. J Sex Marital Ther. 1987 Fall;13(3):219-23. — View Citation

Polyzos NP, Messini CI, Papanikolaou EG, Mauri D, Tzioras S, Badawy A, Messinis IE. Vaginal progesterone gel for luteal phase support in IVF/ICSI cycles: a meta-analysis. Fertil Steril. 2010 Nov;94(6):2083-7. doi: 10.1016/j.fertnstert.2009.12.058. Epub 2010 Feb 19. — View Citation

Practice Committee of the American Society for Reproductive Medicine. Progesterone supplementation during the luteal phase and in early pregnancy in the treatment of infertility: an educational bulletin. Fertil Steril. 2008 Apr;89(4):789-92. doi: 10.1016/j.fertnstert.2008.02.012. — View Citation

Practice Committee of the American Society for Reproductive Medicine. The clinical relevance of luteal phase deficiency: a committee opinion. Fertil Steril. 2012 Nov;98(5):1112-7. doi: 10.1016/j.fertnstert.2012.06.050. Epub 2012 Jul 20. — View Citation

Watson Pharmaceuticals, Inc. Prescribing Information for Crinone. Available at: http://www.crinoneusa.com/professionals/Prescribing_Information.pdf. Retrieved April 22, 2011.

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. Fertil Steril. 2010 Dec;94(7):2596-9. doi: 10.1016/j.fertnstert.2010.02.033. Epub 2010 Mar 27. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Female Change in Progesterone	The primary outcome variables will be: the change in serum progesterone levels increase after coitus in the female partner using vaginal progesterone gel compared to placebo	3 weeks
Secondary	Male Change in Progesterone	The secondary outcome variable will be the change in serum progesterone levels after coitus in the male partner comparing vaginal progesterone gel and placebo.	3 weeks