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PregnancyPhase 3NCT00086177

Vaginal Progesterone to Reduce the Risk of Another Preterm Birth

A Phase 3 study testing 8% progesterone vaginal gel in people with Pregnancy, run by Juniper Pharmaceuticals, Inc. at 45 sites in United States.

Completed

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

Official record
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Trial summary

This research study is being conducted at over 12 pregnancy research centers in the US. The study will compare an investigational treatment with a placebo (a treatment without medication). Neither the investigators nor the patients in the trial will know which treatment has been assigned. 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
Pregnancy
What is being tested?
8% progesterone vaginal gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
636 participants
Where
45 sitesUnited States
Study dates
Apr 2004to Mar 2009
Phase
Phase 3
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

  • The subject has a history of a documented spontaneous singleton preterm delivery (hospital or clinic record, letter from healthcare provider, or birth certificate) from 20 0/7 to 35 0/7 weeks gestational age with the immediate preceding pregnancy or has a cervical length of 2.5 cm or less measured by transvaginal ultrasound with the current pregnancy. "Spontaneous preterm delivery" is a delivery (<35 weeks), either vaginal or cesarean, that is initiated by either preterm PROM followed by contractions or preterm labor initiated with in-tact membranes. A previous preterm delivery secondary to an incompetent cervix where a cerclage is considered for this pregnancy is not considered a preterm delivery (please see Exclusion Criteria No. 10). Subjects enrolled based on a history of preterm delivery may have had a pregnancy loss (or losses) at <20 0/7 weeks gestational age between the preceding preterm delivery and the current pregnancy.
  • The female subject is between 18 and 45 years of age at the time of screening.
  • The pregnancy has an estimated gestational age between 16 0/7 weeks and 22 6/7 weeks.
  • The subject speaks either English or a common local language.
  • The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained, and all her questions are answered to her satisfaction and understanding.
  • In the opinion of the investigator, the subject is able to understand the study and is able to give informed consent, as well as participate in it and adhere to study procedures.

Who cannot join

  • The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel.
  • The subject has been treated with a progestogen within the previous 4 weeks.
  • The subject is currently being treated for a seizure disorder, has an unstable psychiatric disorder, is taking antihypertensive therapy for chronic hypertension at the time of enrollment, has a history of congestive heart failure or chronic renal failure, or has uncontrolled diabetes mellitus (known end-organ dysfunction secondary to vascular disease).
  • The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or thromboembolic disorders.
  • The subject has liver dysfunction or disease.
  • The subject has known or suspected malignancy of the breast or genital organs.
Show all 16Show fewer
  • The subject is currently participating in another investigational study or has participated in an investigational drug study within one month prior to screening for this study.
  • The subject's current pregnancy is complicated by a major fetal anomaly or known chromosomal abnormality.
  • The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus)
  • The subject has a multifetal gestation.
  • The subject has a cervical cerclage in place or has plans to have one placed during the current pregnancy.
  • The subject, in the judgment of the investigator, will be unable or unwilling to comply with study-related assessments and procedures.
  • The subject currently has preterm rupture of membranes, vaginal bleeding, known or suspected amnionitis, or signs or symptoms of preterm labor at the time of enrollment.
  • The subject is HIV positive with a CD4 count of _<350 cells/mm3 and is receiving more than 1 medication to prevent the transfer of AIDS to the fetus.
  • The subject has placenta previa or a low-lying placenta. The subject will be considered for the study if she is not at risk for increased bleeding and has not been given any vaginal precautions.
  • The subject's qualifying preterm delivery was an indicated delivery without preterm labor (i.e. delivery performed for fetal distress, maternal eclampsia/preeclampsia, fetal death, or amnionitis in the absence of contractions).

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

United States45 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Northside Maternal Fetal Specialists

    Atlanta, Georgia, 30342

  • Womens Partner In Health

    Austin, Texas, 78705

  • Johns Hopkins Community Physicians

    Baltimore, Maryland, 21211

  • Maternal Fetal Medicine &Woman's Health Research

    Baton Rouge, Louisiana, 70815

  • Ohio Permanente Medical Group

    Bedford, Ohio, 44146

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • St. Elizabeth's Medical Center -MFM

    Brighton, Massachusetts, 02135

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Regional Obstetrical Consultants

    Chattanooga, Tennessee, 37403

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • MacDonald Clinical Trials Unit, University Hospitals of Cleveland

    Cleveland, Ohio, 44104-5034

  • Women's Health Department

    Colton, California, 92324

  • Health Central Women's Care

    Dallas, Texas, 75231

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Kaiser Permanente

    Denver, Colorado, 80205

  • Pitt County Memorial Hospital

    Greenville, North Carolina, 27834

  • University Medical Group, Dept of OB/GYN

    Greenville, South Carolina, 29605

  • Clinical Research Center of Houston

    Houston, Texas, 77054

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Department of OBGYN, St. Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Maternal Fetal Medicine Norton Suburban Hospital

    Louisville, Kentucky, 40207

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • Gynecology & Obstetrics

    Memphis, Tennessee, 38120

  • University of South Alabama Department of OBGYN

    Mobile, Alabama, 36604

  • West Virginia University

    Morgantown, West Virginia, 26506

  • St. Luke's - Roosevelt Hospital

    New York, New York, 10019

  • EVMS Maternal-Fetal Medicine, Hofheimer Hall

    Norfolk, Virginia, 23507

  • Texas Tech Health Sciences Center - Odessa

    Odessa, Texas, 79763

  • Temple University Medical Center

    Philadelphia, Pennsylvania, 19140

  • SanDiego Perinatal Center

    San Diego, California, 92123

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Louisiana State University Health Sciences Center-Shreveport

    Shreveport, Louisiana, 71103

  • Holy Cross Hospital

    Silver Springs, Maryland, 20910

  • St. Louis University

    St Louis, Missouri, 63021

  • Washington University

    St Louis, Missouri, 63110

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • The Toledo Hospital

    Toledo, Ohio, 43606

  • Harbor - UCLA Medical Center

    Torrance, California, 90509

  • Visions Clinical Research-Tucson

    Tucson, Arizona, 85712

  • Abington Primary Women's Healthcare

    Willow Grove, Pennsylvania, 19090

  • Lyndhurst Gynecologic Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy, Safety, and Tolerability of 8% Progesterone Vaginal Gel in Preventing Preterm Delivery in Pregnant Women at Increased-Risk for Preterm Delivery

This research study is being conducted at over 12 pregnancy research centers in the US. The study will compare an investigational treatment with a placebo (a treatment without medication). Neither the investigators nor the patients in the trial will know which treatment has been assigned. All study medications will be given vaginally once a day. Treatment will begin before pregnancy week 23 and will continue until the end of pregnancy week 36.

Read the detailed description

Patients who participate are to have:

  • A single baby pregnancy (no twins or triplets allowed)
  • Patients will start treatment before pregnancy week 23
  • Patients must have a previous preterm birth (a "preemie")
  • Patients must be 18-45 years of age
Conditions
Pregnancy
Being tested
8% progesterone vaginal gel, Placebo Vaginal Gel
Keywords
Pregnancy,, prevention of preterm birth,, prevention of preterm labor,

What participants receive

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

  • 8% progesterone vaginal gelDrug

    Also called Prochieve, Crinone

    Progesterone 8% Vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation

  • Placebo Vaginal GelDrug

    Placebo vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation

Study groups in NCT00086177
Study groupRoleWhat they receive
1Active comparatorProgesterone 8% vaginal gel
Receives: Drug: 8% progesterone vaginal gel
2Placebo comparatorPlacebo Vaginal Gel
Receives: Drug: Placebo Vaginal Gel

What is being measured

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

  1. Frequency of delivery <=32 weeks

    Measured: 18 weeks gestation through delivery

Secondary outcomes (3)

  1. Frequency of delivery preterm

    Measured: 18 weeks gestation through delivery

  2. Response to tocolytic therapy

    Measured: Onset of preterm labor through resolution or delivery

  3. Number of infant hospital days from delivery to discharge

    Measured: Delivery date through hospital discharge date of infant

Timeline

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

  1. First posted29 Jun 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionJan 2007
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
636 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00086177
Sponsor's protocol ID
COL-1620-300
Status last verified
Aug 2010
First submitted
25 Jun 2004
Last updated
19 Aug 2010
Results posted
No
Data monitoring committee
No

Publications

  • da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2003 Feb;188(2):419-24. doi: 10.1067/mob.2003.41.

    PubMed 12592250

  • O'Brien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S, Soma-Pillay P, Porter K, How H, Schackis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):687-96. doi: 10.1002/uog.5158.

    PubMed 17899572

  • DeFranco EA, O'Brien JM, Adair CD, Lewis DF, Hall DR, Fusey S, Soma-Pillay P, Porter K, How H, Schakis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):697-705. doi: 10.1002/uog.5159.

    PubMed 17899571

  • O'Brien JM, Defranco EA, Adair CD, Lewis DF, Hall DR, How H, Bsharat M, Creasy GW; Progesterone Vaginal Gel Study Group. Effect of progesterone on cervical shortening in women at risk for preterm birth: secondary analysis from a multinational, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2009 Dec;34(6):653-9. doi: 10.1002/uog.7338.

    PubMed 19918965

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 8% progesterone vaginal gel in people with Pregnancy, run by Juniper Pharmaceuticals, Inc. at 45 sites 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 16 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 19 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites 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. Some participants in this study may receive a placebo. 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?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Frequency of delivery <=32 weeks (time frame: 18 weeks gestation through delivery). 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 NCT00086177, which also lists 4 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 19 Aug 2010.

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