AzTrials
AzTrials

PregnancyPhase 2NCT00409825

Study of Pharmacology of 17-OHPC in Pregnancy

A Phase 2 study testing 17-OHPC and Blood Draws in people with Pregnancy, run by University of Pittsburgh at 4 sites 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

We are examining the pharmacology of 17-OHPC in pregnancy, specifically between the second and third trimesters. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Pregnancy
What is being tested?
17-OHPC and Blood Draws
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
4 sitesUnited States
Study dates
Mar 2006to Feb 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • No healthy volunteers
  • Adult

Who may be able to join

  • Singleton gestation prior to 20 0/7 weeks gestation
  • Planning to receive or receiving 17-OHPC (250 mg IM weekly)
  • Previous history of preterm birth
  • Able to give consent

Who cannot join

  • Fetal demise, anomaly, or growth restriction
  • Hepatic or renal dysfunction
  • Placental previa or abruptio placenta
  • Polyhydramnios/oligohydramnios
  • Short cervix or planned cerclage
  • Chronic use of steroids, antiepileptics, antihypertensives, SSRS, street drugs
  • Participation in another interventional study that influences gestational age at delivery
  • Heparin treatment of known platelet count <100,000/mm3 (because of contraindication to intra-muscular injections)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Texas

    Galveston, Texas, 77555

  • Magee-Womens Hospital of University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • University of Washington

    Seattle, Washington, 98195

  • Georgetown University

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Study of the Pharmacology of 17-Hydroxyprogesterone Caproate in Pregnancy

We are examining the pharmacology of 17-OHPC in pregnancy, specifically between the second and third trimesters.

Read the detailed description

The recently completed trial by the National Institute of Child Health and Human Development (NICHD)-sponsored Maternal-Fetal Medicine Units (MFMU) Network has demonstrated that intramuscular 17-alpha-hydroxyprogesterone caproate (17-OHPC) substantially reduces the rate of preterm birth in women at high risk for preterm delivery because of a prior spontaneous preterm birth. No other strategy or treatment for prevention of preterm birth has proven to be effective. Consequently, the American College of Obstetricians and Gynecologists has cautiously supported this treatment but points out that much more information about this therapy and alternative therapies is required. Although a large body of evidence exists about the safety of this treatment, almost nothing is known about the pharmacology of this agent, especially in pregnancy. The purpose of this study is to define the pharmacology of 17-hydroxyprogesterone caproate in pregnancy. This protocol will focus on pharmacokinetics and placental transport and provide preliminary data on the pharmacoepidemiology of 17-OHPC. The primary research question of this study is: Do the pharmacokinetics of 17-OHPC as represented by area under the concentration vs. time curve after IM injection of 250 mg 17-OHPC differ between the second and third trimesters of pregnancy? We will obtain blood samples prior to and daily for one week after injection of 17-OHPC (8 samples total) for each of two parts of the study, with an optional third part for eligible subjects. Additionally, blood samples will be collected prior to each weekly injection of the study drug and at time of delivery. Approximately 60 subjects (ages 18-45) will be accrued at one of the Obstetrical Fetal Pharmacology Research Units (OPRU) Network sites, with 15 at Magee-Womens Hospital of the University of Pittsburgh Medical Center. Study treatment will be administered until delivery. The total duration of this multi-center study is 2-3 years.

Conditions
Pregnancy
Being tested
17-OHPC, Blood Draws

What participants receive

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

  • 17-OHPCDrug

    Also called 17-alpha-hydroxyprogesterone caproate

    Intra-muscular injection of 250 mg 17-OHPC administered weekly between the second and third trimesters of pregnancy, until time of delivery.

  • Blood DrawsProcedure or surgery

    10 cc of blood will be drawn prior to the fifth weekly administration of 17-OHPC during second trimester of pregnancy, and then once daily for seven consecutive days post-dose. 10 cc of blood also will be drawn prior to weekly administration of 17-OHPC from sixth weekly dose in the second trimester until the last scheduled dose in the third trimester. Prior to this last scheduled dose, 10 cc of blood will be drawn, as well as once daily for seven consecutive days post-dose.

Study groups in NCT00409825
Study groupRoleWhat they receive
Part 1ExperimentalPart 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection. A subject in whom Part 2 is performed during the last scheduled injection of 17-OHPC (at or around 35 0/7 weeks) will have the option to participate in Part 3, in which 10 cc of blood will be drawn serially over 21 days after completing Part 2. Blood will be drawn on days 9, 11, 14, 17, 20, 24, 28 after the last injection. Part 4: At the time of labor and delivery, subject will have 10cc of blood removed from a maternal peripheral vein. 10cc of blood will be collected from the placenta/umbilical cord after delivery.
Receives: Drug: 17-OHPC; Procedure: Blood Draws

What is being measured

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

  1. Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy.

    Change in the area under the concentration vs. time curve in the second and third trimesters of pregnancy.

    We compared AUC at each PK study visit. Measurements were obtained at 0, 1, 2, 3, 4, 5, 6, 7 days.

    Measured: Second and third trimesters of pregnancy

Timeline

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

  1. First posted11 Dec 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionApr 2008
  4. Study completionFeb 2014

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 2
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00409825
Sponsor's protocol ID
IRB #0603056
Other IDs
5U10HD047905-02
Status last verified
Feb 2015
First submitted
8 Dec 2006
Last updated
27 Feb 2015
Data monitoring committee
Yes

Publications

  • Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Caritis SN, Iams JD, Wapner RJ, Conway D, O'Sullivan MJ, Carpenter M, Mercer B, Ramin SM, Thorp JM, Peaceman AM, Gabbe S; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003 Jun 12;348(24):2379-85. doi: 10.1056/NEJMoa035140.

    PubMed 12802023

  • ACOG News Release: Progesterone recommended in certain high risk pregnancies to help prevent preterm birth. October 31, 2003

  • Onsrud M, Paus E, Haug E, Kjorstad K. Intramuscular administration of hydroxyprogesterone caproate in patients with endometrial carcinoma. Pharmacokinetics and effects on adrenal function. Acta Obstet Gynecol Scand. 1985;64(6):519-23. doi: 10.3109/00016348509156732.

    PubMed 2932883

  • Kiesling H, Elmquist A: Acta Endocrinol 28:502, 1958

  • GASSNER FX, MARTIN RP, SHIMODA W, ALGEO JW. Metaolism of radioactive steroid esters in the bovine male and female. Fertil Steril. 1960 Jan-Feb;11:49-73. doi: 10.1016/s0015-0282(16)33663-9. No abstract available.

    PubMed 13826776

  • LANGECKER H, HARWART A, JUNKMANN K. [1-Phenyl-propanol as a choleretic]. Naunyn Schmiedebergs Arch Exp Pathol Pharmakol. 1955;225(4):303-8. No abstract available. German.

    PubMed 13253659

  • WIENER M, LUPU CI, PLOTZ EJ. Metabolism of 17 alpha-hydroxyprogesterone-4-C14-17 alpha-caproate by homogenates of rat liver and human placenta. Acta Endocrinol (Copenh). 1961 Apr;36:511-9. No abstract available.

    PubMed 13785108

  • Endocrinology & human gestation. IN: Reproductive Endocrinology, p458. Edited by EY Adashi, Lippincott-Raven Publishers, Philadelphia, PA 1996.

  • Challis JRG, Matthews SG, Gibb W, Lye SJ. Endocrine and paracrine regulation of birth at term and preterm. Endocr Rev. 2000 Oct;21(5):514-50. doi: 10.1210/edrv.21.5.0407.

    PubMed 11041447

  • Johnson JW, Lee PA, Zachary AS, Calhoun S, Migeon CJ. High-risk prematurity--progestin treatment and steroid studies. Obstet Gynecol. 1979 Oct;54(4):412-8.

    PubMed 492618

  • Keirse MJ. Progestogen administration in pregnancy may prevent preterm delivery. Br J Obstet Gynaecol. 1990 Feb;97(2):149-54. doi: 10.1111/j.1471-0528.1990.tb01740.x.

    PubMed 2138496

  • 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

  • Csapo AI. The 'see-saw' theory of parturition. Ciba Found Symp. 1977;(47):159-210. No abstract available.

    PubMed 246391

  • Haluska GJ, Wells TR, Hirst JJ, Brenner RM, Sadowsky DW, Novy MJ. Progesterone receptor localization and isoforms in myometrium, decidua, and fetal membranes from rhesus macaques: evidence for functional progesterone withdrawal at parturition. J Soc Gynecol Investig. 2002 May-Jun;9(3):125-36.

    PubMed 12009386

  • Lye S: Personal communication

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 17-OHPC and Blood Draws in people with Pregnancy, run by University of Pittsburgh at 4 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 4 inclusion and 8 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 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy. (time frame: Second and third trimesters of pregnancy). 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 NCT00409825, which also lists 36 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 27 Feb 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in