17-OHPC in Pregnancy: IM vs SC Routes

NCT04183452 | Terminated FDA Drug

• 1 other identifier: STUDY19110111
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 4

Brief Summary

This study will compare the plasma concentration x time curve or Area Under the Curve (AUC) and the side effects reported with 250 mg intramuscular (IM) and 275 mg subcutaneous (SC) injections of 17-hydroxyprogesterone caproate (17-OHPC).

Conditions

Preterm Birth

Keywords

17-hydroxyprogesterone caproate

Outcome Measures

Primary Outcomes (3)

• Compare the plasma concentration x time curve or the Area Under the Curve (AUC) of the 275 mg subcutaneous dose of 17-OHPC to the 250 mg intramuscular dose of 17-OHPC

  Evaluate the difference between the plasma concentration x time curve or the Area Under the Curve (AUC) at steady state between the 250 mg dose of 17-OHPC administered intramuscularly and the 275 mg dose of 17-OHPC administered subcutaneously with an autoinjector.

  9 weeks after initiation (26-30 weeks gestation)

• Compare the severity of injection related side effects of the intramuscular and subcutaneous routes of administration of 17-OHPC

  Participants will complete a Visual Analog Scale (VAS) with each injection that grades the severity of injection related side effects as none, mild, moderate or severe. This data will be used to compare the side effects of the intramuscular injections to the subcutaneous injections.

  from study initiation until 36 weeks of pregnancy or delivery

• Compare the level of injection related discomfort of the intramuscular and subcutaneous routes of administration of 17-OHPC

  Participants will complete a Visual Analog Scale (VAS) with each injection that grades the level of discomfort associated with the injection as none, mild, moderate or severe. This data will be used to compare the level of discomfort of the intramuscular injections to the subcutaneous injections.

  from study initiation until 36 weeks of pregnancy or delivery

Study Arms (2)

17-Hydroxyprogesterone Caproate 250 mg IM Group

This will be an open label study and participants will not be randomized to a treatment group. The women will be prescribed 17-OHPC by their physicians because of their obstetric history. The investigators will approach pregnant women who are going to be treated with 17-OHPC and ask them to participate. The participants will select the route of administration they prefer, IM or SC. 36 participants will receive the weekly 250 mg IM dose from 16-20 weeks of pregnancy until 36 weeks or delivery.

Drug: 17-Hydroxyprogesterone Caproate 250 mg IM Dose

17-Hydroxyprogesterone Caproate 275 mg SC Group

This will be an open label study and participants will not be randomized to a treatment group. The women will be prescribed 17-OHPC by their physicians because of their obstetric history. The investigators will approach pregnant women who are going to be treated with 17-OHPC and ask them to participate. The participants will select the route of administration they prefer, IM or SC. 36 participants will receive the weekly 275 mg IM dose from 16-20 weeks of pregnancy until 36 weeks or delivery.

Drug: 17-Hydroxyprogesterone Caproate 275 mg SC Dose

Interventions

17-Hydroxyprogesterone Caproate 250 mg IM Dose DRUG

17-Hydroxyprogesterone Caproate is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

Also known as: 17-OHPC

17-Hydroxyprogesterone Caproate 250 mg IM Group

17-Hydroxyprogesterone Caproate 275 mg SC Dose DRUG

17-Hydroxyprogesterone Caproate is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth

Also known as: 17-OHPC

17-Hydroxyprogesterone Caproate 275 mg SC Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: study includes pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This will be an open label study and participants will not be randomized to a treatment group. The rational for this approach is based on the expectation that the primary outcomes (AUC and side effects) will not be affected by provider or patient knowledge of or choice of treatment. We will approach pregnant women who are going to be treated with 17-OHPC as part of their standard of care and ask them to participate. Participants will select the route of administration they prefer, intramuscular or subcutaneous.

You may qualify if:

• Pregnant female with documented prior birth between 16 0/7- 36 6/7 week gestation from spontaneous preterm labor or preterm premature rupture of membranes
• Gestational age (GA) \< 22 weeks, based on study determined GA (as treatment must start between 16 0/7 and 21 6/7 weeks)
• Singleton gestation
• Age between 18 - 45 years
• Able to give informed consent and undergo all study procedures including a single seven day pharmacokinetic study which requires daily venipunctures and willingness to answer questions about side effects and discomfort at each study visit.

You may not qualify if:

• Known major fetal anomaly or chromosomal anomalies that might affect gestational age at delivery
• Malformation of uterus (uterine didelphus, septate uterus or bicornuate uterus)
• Medical or obstetrical complication that might affect gestational age at delivery, such as active ulcerative colitis, liver tumors, liver disease/failure, renal disease/failure, undiagnosed vaginal bleeding unrelated to pregnancy, or hypertension requiring 2 or more agents
• Current or history of thrombosis or thromboembolic disorders
• Known or suspected breast cancer, other hormone-sensitive cancer, or a history of these conditions
• Moderately severe depression (Patient Health Questionnaire-9 (PHQ-9) score ≥15, Edinburgh Postnatal Depression Scale (EPDS) score of \>13, or suicidal ideation)

Sponsors & Collaborators

• Steve N. Caritis, MD: lead
• AMAG Pharmaceuticals, Inc.: collaborator

Study Sites (4)

Christiana Care

Newark, Delaware, 19713, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Pittsburgh-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal blood, 7 mL (1.5 teaspoons) will be collected from a venous catheter daily for 7 days during the pharmacokinetic (PK) study. A single sample will be collected at 3 additional times during the study: after the first injection, after 4-6 injections, and after 14-16 injections.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Steve N Caritis, MD

  University of Pittsburgh-Magee Womens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Obstetrics, Gynecology and Reproductive Science

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: December 3, 2019
• Study Start: June 16, 2020
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: De-identified study data will be provided to AMAG within 6 months after study completion. Serious and unexpected adverse events will be reported to AMAG within three calendar days of the occurrence.

Locations

US (4)