Initiation of Oral Contraception (OC)NCT01750476
Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives
An observational study of Initiation of Oral Contraception (OC) and Initiation of Depo-Provera (DMPA), run by Thomas Cherpes, DVM, MD at 1 site in United States.
Trial summary
The investigators are conducting a research study to understand how cells responsible for fighting infection (immune cells) are affected by hormonal contraceptive use. The investigators hypothesize that progestin-containing hormonal contraceptives (i.e., Depo-Provera) inhibit host response to infection. 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
- Initiation of Oral Contraception (OC), Initiation of Depo-Provera (DMPA), Initiation of Mirena (LNG-IUD)
- What is being tested?
- Mirena, Oral contraception and Depo-Provera
- Type of treatment
- Pill or oral medicine
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2013
- 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 interested in initiating hormonal contraceptive use
Who may be able to join
- 15-25 years of age (inclusive)
- History of regular menstrual cycle
- Not pregnant
- No plan to become pregnant in the next 3 months
- Interested in beginning use of OC, DMPA, or LNG-IUD
- Able to read and provide written informed consent (and consent from a parent/guardian if the participant is a minor)
Who cannot join
- Anticipated move out of area that prevents return for a follow-up visit
- Unavailability for follow-up visit
- Less than 90 days post-partum or post-abortion
- Sexually transmitted infection (STI) diagnosed less than 30 days prior to enrollment
- Use of OC, contraceptive ring or patch, single rod implant, LNG-IUD, or copper-containing IUD less than 3 months prior to enrollment
- DMPA injection less than 6 months prior to enrollment
Show all 10Show fewer
- History of immunosuppressive condition of current use of immunosuppressive medications
- History of a cervical malignancy
- Detection of cervical anatomic pathologic conditions that preclude cervical biopsy procurement
- Intolerance or contradiction to use of OC, DMPA, or LNG-IUD
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Adolescent Clinic of Oakland
Pittsburgh, Pennsylvania, 15213
About this study
The investigators are conducting a research study to understand how cells responsible for fighting infection (immune cells) are affected by hormonal contraceptive use. The investigators hypothesize that progestin-containing hormonal contraceptives (i.e., Depo-Provera) inhibit host response to infection. To test this hypothesis, the investigators will collect blood and genital tract samples from women before and after their initiation of a hormonal contraceptive (either birth control pills, Depo-Provera, or Mirena).
- Conditions
- Initiation of Oral Contraception (OC), Initiation of Depo-Provera (DMPA), Initiation of Mirena (LNG-IUD)
- Being tested
- Mirena, Oral contraception, Depo-Provera
- Keywords
- oral contraception, Depo-Provera, Mirena
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirenaDrug
Oral contraceptionDrug
Depo-ProveraDrug
| Study group | Role | What they receive |
|---|---|---|
| Depo-Provera | Women who choose to initiate Depo-Provera Receives: Drug: Depo-Provera | |
| Mirena | Women who choose to initiate Mirena (intrauterine device) Receives: Drug: Mirena | |
| Oral contraception | Women who choose to initiate oral contraception Receives: Drug: Oral contraception |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proliferative capacity (i.e., ability to respond to antigen stimulation) of T cells isolated from the cervix of women before and after initiating a hormonal contraceptive
Measured: Prior to and ~ 1 month (but up to 2 months) after initiation of a hormonal contraceptive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionJun 2013
Why it stopped: PI and lab have re-located study to The Ohio State University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Initiation of Oral Contraception (OC)Studies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Cherpes, DVM, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Thomas Cherpes, DVM, MD, Ohio State University
- Investigators
- Thomas L. Cherpes, MD, Principal investigator, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750476
- Sponsor's protocol ID
- PRO12010187
- Other IDs
- R01HD072663
- Status last verified
- Jan 2014
- First submitted
- 10 Dec 2012
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- 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 22942424Vicetti Miguel RD, Maryak SA, Cherpes TL. Brefeldin A, but not monensin, enables flow cytometric detection of interleukin-4 within peripheral T cells responding to ex vivo stimulation with Chlamydia trachomatis. J Immunol Methods. 2012 Oct 31;384(1-2):191-5. doi: 10.1016/j.jim.2012.07.018. Epub 2012 Jul 29.
PubMed 22850275
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. 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
- NCT01750476
- Acronym / sponsor ID
- PRO12010187
- Conditions
- Initiation of Oral Contraception (OC), Initiation of Depo-Provera (DMPA), Initiation of Mirena (LNG-IUD)
- Keywords
- oral contraception, Depo-Provera, Mirena
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI and lab have re-located study to The Ohio State University
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Thomas Cherpes, DVM, MDUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Dec 2012 (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.
The investigators are conducting a research study to understand how cells responsible for fighting infection (immune cells) are affected by hormonal contraceptive use. The investigators hypothesize that progestin-containing hormonal contraceptives (i.e., Depo-Provera) inhibit host response to infection. To test this hypothesis, the investigators will collect blood and genital tract samples from women before and after their initiation of a hormonal contraceptive (either birth control pills, Depo-Provera, or Mirena).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depo-Provera | – | Drug: Depo-ProveraWomen who choose to initiate Depo-Provera |
| Mirena | – | Drug: MirenaWomen who choose to initiate Mirena (intrauterine device) |
| Oral contraception | – | Drug: Oral contraceptionWomen who choose to initiate oral contraception |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women interested in initiating hormonal contraceptive use
Key inclusion criteria (6 listed)
- 15-25 years of age (inclusive)
- History of regular menstrual cycle
- Not pregnant
- No plan to become pregnant in the next 3 months
- Interested in beginning use of OC, DMPA, or LNG-IUD
Key exclusion criteria (10 listed)
- Anticipated move out of area that prevents return for a follow-up visit
- Unavailability for follow-up visit
- Less than 90 days post-partum or post-abortion
- Sexually transmitted infection (STI) diagnosed less than 30 days prior to enrollment
- Use of OC, contraceptive ring or patch, single rod implant, LNG-IUD, or copper-containing IUD less than 3 months prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirena | Drug | Mirena |
| Oral contraception | Drug | Oral contraception |
| Depo-Provera | Drug | Depo-Provera |
Primary outcome
Proliferative capacity (i.e., ability to respond to antigen stimulation) of T cells isolated from the cervix of women before and after initiating a hormonal contraceptive
Time frame: Prior to and ~ 1 month (but up to 2 months) after initiation of a hormonal contraceptive
Results and safety
The study was stopped early (reason given: PI and lab have re-located study to The Ohio State University). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
- 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 22850275Vicetti Miguel RD, Maryak SA, Cherpes TL. Brefeldin A, but not monensin, enables flow cytometric detection of interleukin-4 within peripheral T cells responding to ex vivo stimulation with Chlamydia trachomatis. J Immunol Methods. 2012 Oct 31;384(1-2):191-5. doi: 10.1016/j.jim.2012.07.018. Epub 2012 Jul 29.
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
assistant professor
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 Initiation of Oral Contraception (OC) and Initiation of Depo-Provera (DMPA), run by Thomas Cherpes, DVM, MD 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Jan 2014. 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 was stopped early (reason given: PI and lab have re-located study to The Ohio State University). Results are not available in the source record.
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?
Proliferative capacity (i.e., ability to respond to antigen stimulation) of T cells isolated from the cervix of women before and after initiating a hormonal contraceptive (time frame: Prior to and ~ 1 month (but up to 2 months) after initiation of a hormonal contraceptive). 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 NCT01750476, which also lists 2 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 7 Jan 2014.