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| Name | Class |
|---|---|
| Carolinas Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crinone vaginal progesterone gel | Drug | Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley S Hurst, MD | Carolinas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15266541 | Background | Daya S, Gunby J. Luteal phase support in assisted reproduction cycles. Cochrane Database Syst Rev. 2004;(3):CD004830. doi: 10.1002/14651858.CD004830. | |
| 20347079 | 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. |
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publication in manuscript
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Women were enrolled into the study to receive the intervention; male partners also had blood samples taken
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Vaginal Gel Then Crinone | The couple will be given a prefilled applicator containing 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. Then they will be crossed over to Crinone vaginal gel. |
| FG001 | Crinone Vaginal Progesterone Gel Then Placebo | 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 Crinone gel, and have intercourse within 1 hour of insertion of the cream. Then subject will cross over to placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Crinone Vaginal Progesterone Gel Then Placebo | 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 Crinone gel, and have intercourse within 1 hour of insertion of the cream. Then she will cross over to placebo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Full Range | ng/ml | 3 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Vaginal Gel | 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. Placebo vaginal gel: Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradley Hurst, M.D., Director of Assisted Reproduction | Carolinas Healthcare System | 704-355-3149 | bhurst@carolinas.org |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Initial assignment randomized, then crossed over to the other treatment
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| Placebo vaginal gel | Drug | Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator. |
|
| 20171629 | 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. |
| 8062942 | 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. |
| 9329850 | 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. |
| 17671254 | 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. |
| 2936441 | 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. |
| 1473073 | 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. |
| 2959790 | 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. |
| 18251358 | 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. |
| 18406835 | 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. |
| 22819186 | 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. |
| Background | Watson Pharmaceuticals, Inc. Prescribing Information for Crinone. Available at: http://www.crinoneusa.com/professionals/Prescribing_Information.pdf. Retrieved April 22, 2011. |
| 25713585 | Derived | 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. |
| BG001 | Placebo Vaginal Gel Then Crinone | The couple will be given a prefilled applicator containing 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. Then she will cross over to Crinone. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. Crinone vaginal progesterone gel: Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator. |
|
|
| 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. | Posted | Mean | Full Range | ng/ml | 3 weeks |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Crinone Vaginal Progesterone Gel | 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. Crinone vaginal progesterone gel: Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator. | 0 | 20 | 0 | 20 |
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