Gynecological InfectionEarly Phase 1NCT02259309

Immune Modulation by Misoprostol

A Early Phase 1 study testing Misoprostol - buccal and Misoprostol - vaginal in people with Gynecological Infection, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The present study is designed to address the null hypothesis that there is no difference in the local and systemic immunomodulatory effects of buccally or vaginally administered misoprostol in healthy, reproductive-age women. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Gynecological Infection
What is being tested?: Misoprostol - buccal and Misoprostol - vaginal
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Nov 2014to Nov 2015
Phase: Early Phase 1
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 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy women 18-45 years of age
Negative result of urine pregnancy test at screening and prior to each administration of study drug
Normal, regularly occurring menses (being 25-35 day cycles)

Who cannot join

Use of hormonal contraception (current or past 3 months)
Use of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin within two weeks prior to enrollment or planned use of these medications during the study period
Allergy to prostaglandins
Previous cervical cancer
Partial or complete cervical excision
Previous hysterectomy

Show all 12Show fewer

Immunosuppression: either pharmacological or due to comorbidities
Diabetes mellitus
Auto-immune disease
History of lymphoma or leukemia
Sexually transmitted infection (by self-report) over previous 1 year
Bacterial Vaginosis or Candidiasis (current or past 3 months)

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

Conditions: Gynecological Infection
Being tested: Misoprostol - buccal, Misoprostol - vaginal
Keywords: misoprostol, mucosal, cervical, immune, buccal, vaginal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Misoprostol - buccalDrug
Also called Cytotec
buccal administration
Misoprostol - vaginalDrug
Also called Cytotec
vaginal administration

Study groups in NCT02259309
Study group	Role	What they receive
Misoprostol administration - buccal then vaginal	Experimental	Vaginal or buccal administration Receives: Drug: Misoprostol - buccal; Drug: Misoprostol - vaginal
Misoprostol administration - vaginal then buccal	Experimental	Vaginal or buccal administration Receives: Drug: Misoprostol - buccal; Drug: Misoprostol - vaginal

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of misoprostol drug levels in patients after vaginal and buccal administration
Peripheral blood collected at Days 0, 1, 28, and 29
Measured: Peripheral blood collected at Days 0, 1, 28, and 29
Comparison of cytokine and chemokine levels in patients after vaginal and buccal administration
Peripheral blood collected at Days 0, 1, 28, and 29
Measured: Peripheral blood collected at Days 0, 1, 28, and 29
Determination of immune cell activation state after vaginal and buccal administration
Peripheral blood collected at Days 0, 1, 28, and 29
Measured: Peripheral blood collected at Days 0, 1, 28, and 29
Comparison of misoprostol drug levels in patients after vaginal and buccal administration
Cervicovaginal lavage at Days 0, 1, 28, and 29
Measured: Cervicovaginal lavage at Days 0, 1, 28, and 29
Comparison of cytokine and chemokine levels in patients after vaginal and buccal administration
Cervicovaginal lavage at Days 0, 1, 28, and 29
Measured: Cervicovaginal lavage at Days 0, 1, 28, and 29
Determination of immune cell activation state after vaginal and buccal administration
Cervical cytobrush at Days 0, 1, 28, and 29
Measured: Cervical cytobrush at Days 0, 1, 28, and 29

Secondary outcomes (1)

Sequencing of 16S rRNA gene for microbial ecology studies after vaginal and buccal administration
Vaginal swab at Days 0, 1, 28, and 29
Measured: Vaginal swab at Days 0, 1, 28, and 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Nov 2015

First posted8 Oct 2014 (estimated)
Study startNov 2014
Primary completionJul 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Gynecological InfectionStudies 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: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02259309
Sponsor's protocol ID: 140667
Status last verified: Jan 2016
First submitted: 22 Sep 2014
Last updated: 14 Jan 2016
Results posted: No
Data monitoring committee: No

Publications

Moran M, Mozes MF, Maddux MS, Veremis S, Bartkus C, Ketel B, Pollak R, Wallemark C, Jonasson O. Prevention of acute graft rejection by the prostaglandin E1 analogue misoprostol in renal-transplant recipients treated with cyclosporine and prednisone. N Engl J Med. 1990 Apr 26;322(17):1183-8. doi: 10.1056/NEJM199004263221703.
PubMed 2109195
Pouteil-Noble C, Chapuis F, Berra N, Hadj-Aissa A, Lacavalerie B, Lefrancois N, Martin X, Touraine JL. Misoprostol in renal transplant recipients: a prospective, randomized, controlled study on the prevention of acute rejection episodes and cyclosporin A nephrotoxicity. Nephrol Dial Transplant. 1994;9(5):552-5. doi: 10.1093/ndt/9.5.552.
PubMed 8090337
Zieman M, Fong SK, Benowitz NL, Banskter D, Darney PD. Absorption kinetics of misoprostol with oral or vaginal administration. Obstet Gynecol. 1997 Jul;90(1):88-92. doi: 10.1016/S0029-7844(97)00111-7.
PubMed 9207820
Waiser J, Bohler T, Stoll J, Schumann B, Budde K, Neumayer HH. The immunosuppressive potential of misoprostol--efficacy and variability. Clin Immunol. 2003 Dec;109(3):288-94. doi: 10.1016/j.clim.2003.08.009.
PubMed 14697743
Middleton T, Schaff E, Fielding SL, Scahill M, Shannon C, Westheimer E, Wilkinson T, Winikoff B. Randomized trial of mifepristone and buccal or vaginal misoprostol for abortion through 56 days of last menstrual period. Contraception. 2005 Nov;72(5):328-32. doi: 10.1016/j.contraception.2005.05.017. Epub 2005 Aug 9.
PubMed 16246656
Tang OS, Ho PC. The pharmacokinetics and different regimens of misoprostol in early first-trimester medical abortion. Contraception. 2006 Jul;74(1):26-30. doi: 10.1016/j.contraception.2006.03.005. Epub 2006 Apr 27.
PubMed 16781256
el-Refaey H, Rajasekar D, Abdalla M, Calder L, Templeton A. Induction of abortion with mifepristone (RU 486) and oral or vaginal misoprostol. N Engl J Med. 1995 Apr 13;332(15):983-7. doi: 10.1056/NEJM199504133321502.
PubMed 7885426
Ho PC, Ngai SW, Liu KL, Wong GC, Lee SW. Vaginal misoprostol compared with oral misoprostol in termination of second-trimester pregnancy. Obstet Gynecol. 1997 Nov;90(5):735-8. doi: 10.1016/S0029-7844(97)00419-5.
PubMed 9351755
Silverstein FE, Graham DY, Senior JR, Davies HW, Struthers BJ, Bittman RM, Geis GS. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1995 Aug 15;123(4):241-9. doi: 10.7326/0003-4819-123-4-199508150-00001.
PubMed 7611589
Herting RL, Clay GA. Overview of clinical safety with misoprostol. Dig Dis Sci. 1985 Nov;30(11 Suppl):185S-193S. doi: 10.1007/BF01309407.
PubMed 3932053
Wildeman RA. Focus on misoprostol: review of worldwide safety data. Clin Invest Med. 1987 May;10(3):243-5.
PubMed 3113801
Rostom A, Dube C, Wells G, Tugwell P, Welch V, Jolicoeur E, McGowan J. Prevention of NSAID-induced gastroduodenal ulcers. Cochrane Database Syst Rev. 2002;(4):CD002296. doi: 10.1002/14651858.CD002296.
PubMed 12519573
Chong E, Tsereteli T, Nguyen NN, Winikoff B. A randomized controlled trial of different buccal misoprostol doses in mifepristone medical abortion. Contraception. 2012 Sep;86(3):251-6. doi: 10.1016/j.contraception.2011.12.012. Epub 2012 Feb 2.
PubMed 22305917
Raymond EG, Shannon C, Weaver MA, Winikoff B. First-trimester medical abortion with mifepristone 200 mg and misoprostol: a systematic review. Contraception. 2013 Jan;87(1):26-37. doi: 10.1016/j.contraception.2012.06.011. Epub 2012 Aug 13.
PubMed 22898359
Kotsonis FN, Dodd DC, Regnier B, Kohn FE. Preclinical toxicology profile of misoprostol. Dig Dis Sci. 1985 Nov;30(11 Suppl):142S-146S. doi: 10.1007/BF01309401.
PubMed 3932047

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immune Modulation by Misoprostol
ClinicalTrials.gov ID: NCT02259309
Acronym / sponsor ID: 140667
Conditions: Gynecological Infection
Keywords: misoprostol, mucosal, cervical, immune, buccal, vaginal
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Collaborators: Gynuity Health Projects
Study start: Nov 2014
Primary completion: Jul 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 8 Oct 2014 (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.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Misoprostol administration - buccal then vaginal	Experimental	Drug: Misoprostol - buccal, Drug: Misoprostol - vaginalVaginal or buccal administration
Misoprostol administration - vaginal then buccal	Experimental	Drug: Misoprostol - buccal, Drug: Misoprostol - vaginalVaginal or buccal administration

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy women 18-45 years of age
Negative result of urine pregnancy test at screening and prior to each administration of study drug
Normal, regularly occurring menses (being 25-35 day cycles)

Key exclusion criteria (12 listed)

Use of hormonal contraception (current or past 3 months)
Use of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin within two weeks prior to enrollment or planned use of these medications during the study period
Allergy to prostaglandins
Previous cervical cancer
Partial or complete cervical excision

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
Misoprostol - buccalAlso: Cytotecbuccal administration	Drug	Misoprostol administration - buccal then vaginal, Misoprostol administration - vaginal then buccal
Misoprostol - vaginalAlso: Cytotecvaginal administration	Drug	Misoprostol administration - buccal then vaginal, Misoprostol administration - vaginal then buccal

Primary outcome

Comparison of misoprostol drug levels in patients after vaginal and buccal administration
Time frame: Peripheral blood collected at Days 0, 1, 28, and 29
Peripheral blood collected at Days 0, 1, 28, and 29
Comparison of cytokine and chemokine levels in patients after vaginal and buccal administration
Time frame: Peripheral blood collected at Days 0, 1, 28, and 29
Peripheral blood collected at Days 0, 1, 28, and 29
Determination of immune cell activation state after vaginal and buccal administration
Time frame: Peripheral blood collected at Days 0, 1, 28, and 29
Peripheral blood collected at Days 0, 1, 28, and 29
Comparison of misoprostol drug levels in patients after vaginal and buccal administration
Time frame: Cervicovaginal lavage at Days 0, 1, 28, and 29
Cervicovaginal lavage at Days 0, 1, 28, and 29
Comparison of cytokine and chemokine levels in patients after vaginal and buccal administration
Time frame: Cervicovaginal lavage at Days 0, 1, 28, and 29
Cervicovaginal lavage at Days 0, 1, 28, and 29
Determination of immune cell activation state after vaginal and buccal administration
Time frame: Cervical cytobrush at Days 0, 1, 28, and 29
Cervical cytobrush at Days 0, 1, 28, and 29

1 secondary outcome

Sequencing of 16S rRNA gene for microbial ecology studies after vaginal and buccal administration
Time frame: Vaginal swab at Days 0, 1, 28, and 29

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 14 Jan 2016.
Background: PubMed 2109195Moran M, Mozes MF, Maddux MS, Veremis S, Bartkus C, Ketel B, Pollak R, Wallemark C, Jonasson O. Prevention of acute graft rejection by the prostaglandin E1 analogue misoprostol in renal-transplant recipients treated with cyclosporine and prednisone. N Engl J Med. 1990 Apr 26;322(17):1183-8. doi: 10.1056/NEJM199004263221703.
Background: PubMed 8090337Pouteil-Noble C, Chapuis F, Berra N, Hadj-Aissa A, Lacavalerie B, Lefrancois N, Martin X, Touraine JL. Misoprostol in renal transplant recipients: a prospective, randomized, controlled study on the prevention of acute rejection episodes and cyclosporin A nephrotoxicity. Nephrol Dial Transplant. 1994;9(5):552-5. doi: 10.1093/ndt/9.5.552.
Background: PubMed 9207820Zieman M, Fong SK, Benowitz NL, Banskter D, Darney PD. Absorption kinetics of misoprostol with oral or vaginal administration. Obstet Gynecol. 1997 Jul;90(1):88-92. doi: 10.1016/S0029-7844(97)00111-7.
Background: PubMed 14697743Waiser J, Bohler T, Stoll J, Schumann B, Budde K, Neumayer HH. The immunosuppressive potential of misoprostol--efficacy and variability. Clin Immunol. 2003 Dec;109(3):288-94. doi: 10.1016/j.clim.2003.08.009.
Background: PubMed 16246656Middleton T, Schaff E, Fielding SL, Scahill M, Shannon C, Westheimer E, Wilkinson T, Winikoff B. Randomized trial of mifepristone and buccal or vaginal misoprostol for abortion through 56 days of last menstrual period. Contraception. 2005 Nov;72(5):328-32. doi: 10.1016/j.contraception.2005.05.017. Epub 2005 Aug 9.
Background: PubMed 16781256Tang OS, Ho PC. The pharmacokinetics and different regimens of misoprostol in early first-trimester medical abortion. Contraception. 2006 Jul;74(1):26-30. doi: 10.1016/j.contraception.2006.03.005. Epub 2006 Apr 27.
Background: PubMed 7885426el-Refaey H, Rajasekar D, Abdalla M, Calder L, Templeton A. Induction of abortion with mifepristone (RU 486) and oral or vaginal misoprostol. N Engl J Med. 1995 Apr 13;332(15):983-7. doi: 10.1056/NEJM199504133321502.
Background: PubMed 9351755Ho PC, Ngai SW, Liu KL, Wong GC, Lee SW. Vaginal misoprostol compared with oral misoprostol in termination of second-trimester pregnancy. Obstet Gynecol. 1997 Nov;90(5):735-8. doi: 10.1016/S0029-7844(97)00419-5.
Background: PubMed 7611589Silverstein FE, Graham DY, Senior JR, Davies HW, Struthers BJ, Bittman RM, Geis GS. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1995 Aug 15;123(4):241-9. doi: 10.7326/0003-4819-123-4-199508150-00001.
Background: PubMed 3932053Herting RL, Clay GA. Overview of clinical safety with misoprostol. Dig Dis Sci. 1985 Nov;30(11 Suppl):185S-193S. doi: 10.1007/BF01309407.
Background: PubMed 3113801Wildeman RA. Focus on misoprostol: review of worldwide safety data. Clin Invest Med. 1987 May;10(3):243-5.
Background: PubMed 12519573Rostom A, Dube C, Wells G, Tugwell P, Welch V, Jolicoeur E, McGowan J. Prevention of NSAID-induced gastroduodenal ulcers. Cochrane Database Syst Rev. 2002;(4):CD002296. doi: 10.1002/14651858.CD002296.

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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.

David M. Aronoff, MD principal investigator

Vanderbilt University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Misoprostol - buccal and Misoprostol - vaginal in people with Gynecological Infection, run by Vanderbilt University 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 3 inclusion and 12 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 14 Jan 2016. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Comparison of misoprostol drug levels in patients after vaginal and buccal administration (time frame: Peripheral blood collected at Days 0, 1, 28, and 29). The study lists 6 primary outcomes in all. 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 NCT02259309, which also lists 18 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 14 Jan 2016.