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Sexual Absorption of Vaginal Progesterone

Primary Purpose

Infertility, Pregnancy

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Crinone vaginal progesterone gel

Placebo vaginal gel

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring Assisted reproductive technology, Infertility, Progesterone, Vaginal gel, Luteal-phase support

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Crinone vaginal progesterone gel

Placebo vaginal gel

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01959464

First Posted

October 8, 2013

Last Updated

April 20, 2022

Sponsor

Wake Forest University Health Sciences

Collaborators

Carolinas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01959464

Brief Title

Sexual Absorption of Vaginal Progesterone

Official Title

Sexual Absorption of Vaginal Progesterone

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

Carolinas Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Pregnancy

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Model Description

Initial assignment randomized, then crossed over to the other treatment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Crinone vaginal progesterone gel

Arm Type

Experimental

Arm Description

Arm Title

Placebo vaginal gel

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Crinone vaginal progesterone gel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo vaginal gel

Intervention Description

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

Primary Outcome Measure Information:

Title

Female Change in Progesterone

Description

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

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Male Change in Progesterone

Description

The secondary outcome variable will be the change in serum progesterone levels after coitus in the male partner comparing vaginal progesterone gel and placebo.

Time Frame

3 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bradley S Hurst, MD

Organizational Affiliation

Carolinas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Carolinas Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

publication in manuscript

Citations:

PubMed Identifier

15266541

Citation

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

Results Reference

background

PubMed Identifier

20347079

Citation

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.

Results Reference

background

PubMed Identifier

20171629

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.

Results Reference

background

PubMed Identifier

8062942

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

Results Reference

background

PubMed Identifier

9329850

Citation

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.

Results Reference

background

PubMed Identifier

17671254

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. doi: 10.1056/NEJMoa067815.

Results Reference

background

PubMed Identifier

2936441

Citation

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.

Results Reference

background

PubMed Identifier

1473073

Citation

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.

Results Reference

background

PubMed Identifier

2959790

Citation

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.

Results Reference

background

PubMed Identifier

18251358

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.

Results Reference

background

PubMed Identifier

18406835

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.

Results Reference

background

PubMed Identifier

22819186

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.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

25713585

Citation

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.

Results Reference

derived

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Sexual Absorption of Vaginal Progesterone

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