17-OHPC in Pregnancy: IM vs SC Routes

NCT ID: NCT04183452

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2023-04-06

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).

Detailed Description

17-hydroxyprogesterone caproate (17-OHPC) is used in women with a prior preterm birth (PTB) as it reduces recurrences by a third. The drug is administered intramuscularly (IM) but that creates discomfort and in many instances requires repeated office visits as the drug is administered weekly from 16-20 weeks until 36 weeks or delivery. AMAG Pharmaceuticals obtained FDA approval to administer the drug subcutaneously (SC) based on demonstration of bioequivalence of a dose of 275 mg SC to a dose of 250 mg IM. That bioequivalence study was performed in postmenopausal women who received a single dose. This study will be performed in pregnant women with repeated injections both to demonstrate that equivalent exposure is seen and to assess the side effects and acceptance of each route of administration.

A pharmacokinetic (PK) study will be performed after participants have reached steady state (after 9 injections). Participants will receive their injections from research personnel up until the time of completion of the PK study. Home injections will be an option for all participants after the PK study is completed.

Conditions

Preterm Birth

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

17-Hydroxyprogesterone Caproate 250 mg IM Dose

Intervention Type: 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.

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.

17-Hydroxyprogesterone Caproate 275 mg SC Dose

Intervention Type: 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

Interventions

17-Hydroxyprogesterone Caproate 250 mg IM Dose

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.

Intervention Type: DRUG

17-Hydroxyprogesterone Caproate 275 mg SC Dose

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

Intervention Type: DRUG

Other Intervention Names

17-OHPC; 17-OHPC

Eligibility Criteria

Inclusion Criteria

1. 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

2. Gestational age (GA) < 22 weeks, based on study determined GA (as treatment must start between 16 0/7 and 21 6/7 weeks)

3. Singleton gestation

4. Age between 18 - 45 years

5. 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.

Exclusion Criteria

1. Known major fetal anomaly or chromosomal anomalies that might affect gestational age at delivery

2. Malformation of uterus (uterine didelphus, septate uterus or bicornuate uterus)

3. 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

4. Current or history of thrombosis or thromboembolic disorders

5. Known or suspected breast cancer, other hormone-sensitive cancer, or a history of these conditions

6. Moderately severe depression (Patient Health Questionnaire-9 (PHQ-9) score ≥15, Edinburgh Postnatal Depression Scale (EPDS) score of >13, or suicidal ideation)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AMAG Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Steve N. Caritis, MD

OTHER

Sponsor Role: lead

Responsible Party

Steve N. Caritis, MD

Professor Obstetrics, Gynecology and Reproductive Science

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Steve N Caritis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh-Magee Womens Hospital

Locations

Christiana Care

Newark, Delaware, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

University of Pittsburgh-Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY19110111

Identifier Type: -

Identifier Source: org_study_id