Preterm BirthNCT04183452
17-OHPC in Pregnancy: IM vs SC Routes
An observational study of Preterm Birth, run by Steve N. Caritis, MD at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- 17-Hydroxyprogesterone Caproate 250 mg IM Dose and 17-Hydroxyprogesterone Caproate 275 mg SC Dose
- How many people
- 24 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Jun 2020to 6 Apr 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke University Medical Center
Durham, North Carolina, 27710
Christiana Care
Newark, Delaware, 19713
University of Pittsburgh-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Comparison of Intramuscular and Subcutaneous Administration of 17-hydroxyprogesterone Caproate (17-OHPC) in Pregnancy
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).
Read the 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
- Being tested
- 17-Hydroxyprogesterone Caproate 250 mg IM Dose, 17-Hydroxyprogesterone Caproate 275 mg SC Dose
- Keywords
- 17-hydroxyprogesterone caproate
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-Hydroxyprogesterone Caproate 250 mg IM DoseDrug
Also called 17-OHPC
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 DoseDrug
Also called 17-OHPC
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 17-Hydroxyprogesterone Caproate 275 mg SC Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: from study initiation until 36 weeks of pregnancy or delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start16 Jun 2020
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Why it stopped: Sponsor stopped study as the study drugs were withdrawn from the market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steve N. Caritis, MD
- Sponsor type
- University, hospital or other
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Steve N. Caritis, MD, University of Pittsburgh
- Investigators
- Steve N Caritis, MD, Principal investigator, University of Pittsburgh-Magee Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183452
- Sponsor's protocol ID
- STUDY19110111
- Status last verified
- Aug 2023
- First submitted
- 19 Nov 2019
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigator shall furnish AMAG Pharmaceuticals with the data resulting from the study, excluding any patient identifiable information. The investigator will also notify AMAG Pharmacovigilance of all serious and unexpected adverse events and provide copies of communications to and from a regulatory authority. The investigator will also provide a copy of the written consent and Institutional Review Board (IRB) approvals or renewals.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Intramuscular and Subcutaneous Administration of 17-hydroxyprogesterone Caproate (17-OHPC) in Pregnancy
- ClinicalTrials.gov ID
- NCT04183452
- Acronym / sponsor ID
- STUDY19110111
- Conditions
- Preterm Birth
- Keywords
- 17-hydroxyprogesterone caproate
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor stopped study as the study drugs were withdrawn from the market
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Steve N. Caritis, MDUniversity, hospital or other
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 3 Dec 2019 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 17-Hydroxyprogesterone Caproate 250 mg IM Group | – | Drug: 17-Hydroxyprogesterone Caproate 250 mg IM DoseThis 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 275 mg SC Group | – | Drug: 17-Hydroxyprogesterone Caproate 275 mg SC DoseThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| 17-Hydroxyprogesterone Caproate 250 mg IM DoseAlso: 17-OHPC17-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. | Drug | 17-Hydroxyprogesterone Caproate 250 mg IM Group |
| 17-Hydroxyprogesterone Caproate 275 mg SC DoseAlso: 17-OHPC17-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 | Drug | 17-Hydroxyprogesterone Caproate 275 mg SC Group |
Primary outcome
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
Time frame: 9 weeks after initiation (26-30 weeks gestation)
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.
Compare the severity of injection related side effects of the intramuscular and subcutaneous routes of administration of 17-OHPC
Time frame: from study initiation until 36 weeks of pregnancy or delivery
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.
Compare the level of injection related discomfort of the intramuscular and subcutaneous routes of administration of 17-OHPC
Time frame: from study initiation until 36 weeks of pregnancy or delivery
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.
Results and safety
The study was stopped early (reason given: Sponsor stopped study as the study drugs were withdrawn from the market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: Yes. The investigator shall furnish AMAG Pharmaceuticals with the data resulting from the study, excluding any patient identifiable information. The investigator will also notify AMAG Pharmacovigilance of all serious and unexpected adverse events and provide copies of communications to and from a regulatory authority. The investigator will also provide a copy of the written consent and Institutional Review Board (IRB) approvals or renewals.
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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.
Steve N Caritis, MD principal investigator
University of Pittsburgh-Magee Womens Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by Steve N. Caritis, MD 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 Aug 2023. 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.
Are results available for this study?
The study was stopped early (reason given: Sponsor stopped study as the study drugs were withdrawn from the market). Results are not available in the source record.
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?
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 (time frame: 9 weeks after initiation (26-30 weeks gestation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2023.