Sexual Absorption of Vaginal Progesterone

NCT01959464 | Completed Phase 4 Results DMC

• 1 other identifier: SAVP2013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility; Pregnancy

Keywords

Assisted reproductive technology; Infertility; Progesterone; Vaginal gel; Luteal-phase support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Male Change in Progesterone

  3 weeks

Study Arms (2)

Crinone vaginal progesterone gel

EXPERIMENTAL

Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg of progesterone. The reported time to maximum progesterone concentration is 6.8 +/- 3.3 hours with use of a single dose of Crinone 8%. Absorption half-life is approximately 25-50 hours and an elimination half-life of 5-20 minutes. On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream.

Drug: Crinone vaginal progesterone gel

Placebo vaginal gel

PLACEBO COMPARATOR

The couple will be given a prefilled applicator containing either Crinone gel (progesterone) or placebo vaginal gel, data collection sheets and laboratory requisitions. On the evening of day 3, the female will insert the applicator into the vagina, administer the gel, and have intercourse within 1 hour of insertion of the cream.

Drug: Placebo vaginal gel

Interventions

Crinone vaginal progesterone gel DRUG

Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator.

Crinone vaginal progesterone gel

Placebo vaginal gel DRUG

Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator.

Placebo vaginal gel

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Carolinas Medical Center: collaborator

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Related Publications (14)

• Daya S, Gunby J. Luteal phase support in assisted reproduction cycles. Cochrane Database Syst Rev. 2004;(3):CD004830. doi: 10.1002/14651858.CD004830.

  PMID: 15266541 BACKGROUND

• 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.

  PMID: 20347079 BACKGROUND

• 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.

  PMID: 20171629 BACKGROUND

• 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. doi: 10.1016/s0015-0282(16)56935-0.

  PMID: 8062942 BACKGROUND

• De Ziegler D, Bulletti C, De Monstier B, Jaaskelainen AS. The first uterine pass effect. Ann N Y Acad Sci. 1997 Sep 26;828:291-9. doi: 10.1111/j.1749-6632.1997.tb48550.x.

  PMID: 9329850 BACKGROUND

• 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. doi: 10.1056/NEJMoa067815.

  PMID: 17671254 BACKGROUND

• Cooper AJ. Progestogens in the treatment of male sex offenders: a review. Can J Psychiatry. 1986 Feb;31(1):73-9. doi: 10.1177/070674378603100116.

  PMID: 2936441 BACKGROUND

• 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. doi: 10.1177/070674379203701003.

  PMID: 1473073 BACKGROUND

• Money J. Treatment guidelines: antiandrogen and counseling of paraphilic sex offenders. J Sex Marital Ther. 1987 Fall;13(3):219-23. doi: 10.1080/00926238708403894.

  PMID: 2959790 BACKGROUND

• 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.

  PMID: 18251358 BACKGROUND

• 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.

  PMID: 18406835 BACKGROUND

• 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.

  PMID: 22819186 BACKGROUND

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

  BACKGROUND

• Merriam KS, Leake KA, Elliot M, Matthews ML, Usadi RS, Hurst BS. Sexual absorption of vaginal progesterone: a randomized control trial. Int J Endocrinol. 2015;2015:685281. doi: 10.1155/2015/685281. Epub 2015 Feb 3.

  PMID: 25713585 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Bradley Hurst, M.D., Director of Assisted Reproduction
• Organization: Carolinas Healthcare System

bhurst@carolinas.org

704-355-3149

Study Officials

• Bradley S Hurst, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Initial assignment randomized, then crossed over to the other treatment

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: November 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 22, 2022
• Results First Posted: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)