ContraceptionNCT02011711
Modulation of Immunity by Hormonal Contraceptives
An observational study of Contraception, run by Thomas L. Cherpes at 1 site in United States.
Trial summary
Clinical study to determine if hormonal contraceptive use effects cells that fight infection (i.e., immune cells). Read more about this study
- Who is it for?
- Ages 15 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women seeking to initiate use of an oral contraceptive, depot-medroxyprogesterone acetate, or Mirena.
Who may be able to join
- not pregnant
- regular menstrual cycle
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives
Clinical study to determine if hormonal contraceptive use effects cells that fight infection (i.e., immune cells).
Read the 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.
- Conditions
- Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mirena | Women interested in beginning use of Mirena | |
| Depot-medroxyprogesterone acetate | Women interested in beginning use of depot-medroxyprogesterone acetate | |
| Oral Contraception | Women interested in beginning use of oral contraception |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ectocervical permeability
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas L. Cherpes
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Thomas L. Cherpes, Stanford University
- Investigators
- Thomas L Cherpes, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011711
- Sponsor's protocol ID
- 2013H0235
- Other IDs
- R01HD072663
- Status last verified
- Jan 2017
- First submitted
- 10 Dec 2013
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22942424Quispe 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.
PubMed 27892938Quispe 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.
PubMed 25740884Quispe 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.
PubMed 27007679Quispe 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.
PubMed 27599006
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives
- ClinicalTrials.gov ID
- NCT02011711
- Acronym / sponsor ID
- 2013H0235
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Thomas L. CherpesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirena | – | –Women interested in beginning use of Mirena |
| Depot-medroxyprogesterone acetate | – | –Women interested in beginning use of depot-medroxyprogesterone acetate |
| Oral Contraception | – | –Women interested in beginning use of oral contraception |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women seeking to initiate use of an oral contraceptive, depot-medroxyprogesterone acetate, or Mirena.
Key inclusion criteria (2 listed)
- not pregnant
- regular menstrual cycle
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in ectocervical permeability
Time frame: Baseline and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Background: PubMed 22942424Vicetti 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.
- Background: PubMed 27892938Quispe 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.
- Results publication: PubMed 25740884Quispe 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.
- Results publication: PubMed 27007679Quispe 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.
- Results publication: PubMed 27599006Quispe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas L Cherpes, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Thomas L. Cherpes at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ectocervical permeability (time frame: Baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02011711, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.