Clinical trial NCT02011711: Modulation of Immunity by Hormonal Contraceptives
Official title: Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-12-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women seeking to initiate use of an oral contraceptive, depot-medroxyprogesterone acetate, or Mirena.

Brief summary: Clinical study to determine if hormonal contraceptive use effects cells that fight infection (i.e., immune cells).

Detailed description: Feminization of the HIV pandemic is impetus for better understanding of the risk factors promoting male to female sexual transmission. One putative risk factor is hormonal contraceptive use. Our laboratory recently reported that dendritic cell activation, virus-specific T cell expansion, and memory T cell development were impaired among female mice administered depot-medroxyprogesterone acetate (DMPA) prior to viral infection of mucosal tissue, and we now are enrolling women into a clinical investigation exploring the immunomodulatory effects of several common hormonal contraceptive forms. Completion of this research will provide important comparative evaluation of the capacity of these drugs to modulate host defenses combating genital tract infection, eventually supplying healthcare providers more informed recommendations regarding appropriate hormonal contraceptive choices among women at risk for acquisition of HIV.

Eligibility criteria: Inclusion Criteria:

* not pregnant
* regular menstrual cycle

Exclusion Criteria:

* use of oral contraceptive or Mirena in 3 months prior to enrollment
* use of depot-medroxyprogesterone acetate in 6 months prior to enrollment
* diagnosis of sexually transmitted infection in 30 days prior to enrollment
* history of cervical malignancy

Primary outcomes:
measure: Change in ectocervical permeability
timeFrame: Baseline and 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Edwards Building
state: California
Study officials:
affiliation: Stanford University
name: Thomas L Cherpes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vicetti Miguel RD, Hendricks RL, Aguirre AJ, Melan MA, Harvey SA, Terry-Allison T, St Leger AJ, Thomson AW, Cherpes TL. Dendritic cell activation and memory cell development are impaired among mice administered medroxyprogesterone acetate prior to mucosal herpes simplex virus type 1 infection. J Immunol. 2012 Oct 1;189(7):3449-61. doi: 10.4049/jimmunol.1103054. Epub 2012 Aug 31.
citation: Quispe Calla NE, Vicetti Miguel RD, Mei A, Fan S, Gilmore JR, Cherpes TL. Dendritic cell function and pathogen-specific T cell immunity are inhibited in mice administered levonorgestrel prior to intranasal Chlamydia trachomatis infection. Sci Rep. 2016 Nov 28;6:37723. doi: 10.1038/srep37723.
citation: Quispe Calla NE, Ghonime MG, Cherpes TL, Vicetti Miguel RD. Medroxyprogesterone acetate impairs human dendritic cell activation and function. Hum Reprod. 2015 May;30(5):1169-77. doi: 10.1093/humrep/dev035. Epub 2015 Mar 3.
citation: Quispe Calla NE, Vicetti Miguel RD, Boyaka PN, Hall-Stoodley L, Kaur B, Trout W, Pavelko SD, Cherpes TL. Medroxyprogesterone acetate and levonorgestrel increase genital mucosal permeability and enhance susceptibility to genital herpes simplex virus type 2 infection. Mucosal Immunol. 2016 Nov;9(6):1571-1583. doi: 10.1038/mi.2016.22. Epub 2016 Mar 23.
citation: Quispe Calla NE, Vicetti Miguel RD, Trout W, Cherpes TL. HIV and Hormonal Contraception: Bench and Bedside. J Acquir Immune Defic Syndr. 2017 Mar 1;74(3):e85-e86. doi: 10.1097/QAI.0000000000001174. No abstract available.