Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal WomenPhase 3NCT02937766

Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women

A Phase 3 study testing Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in people with Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women, run by AMAG Pharmaceuticals, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered subcutaneously via auto-injector is associated with less pain as compared to intramuscular injections of Makena® Read more about this study

Who is it for?: Ages 50 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for: Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women
What is being tested?: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 7 Oct 2016to 27 Mar 2017
Phase: Phase 3
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 50 to 75 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female subjects aged 50 to 75 years of age, inclusive, at Screening Visit.
Follicle stimulating hormone (FSH) levels greater than 40 mIU/mL.
Naturally or surgically postmenopausal with or without an intact uterus.

Who cannot join

Have history of or positive test results for HIV or hepatitis B or C.
A significant history or current evidence of chronic infectious disease, organ dysfunction especially cardiovascular, renal, or hepatic disorders or other medical condition.
Receiving or have received chronic opioid therapy within 12 months.
Unwilling to stop taking/using:
pain medication.
topical analgesic or anti-inflammatory treatment. Topical analgesics must be washed out by at least 72 hours in the areas to be treated before randomization.

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History of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse in the last 12 months.
Currently taking any estrogen/progesterone hormone replacement therapy (HRT).
History of allergy or sensitivity to hydroxyprogesterone caproate, castor oil or any of the constituents of the study medications or history of any drug hypersensitivity or intolerance.
Poorly controlled diabetes (Hgb A1C >8).
Current or history of thrombosis or thromboembolic disorders.
Known or suspected breast cancer, other hormone-sensitive cancer or tumor, or history of these conditions within the last 5 years.
Any current or recent (within previous 12 months) vaginal bleeding.
Uncontrolled hypertension.
A chronic pain condition (i.e. chronic back pain) that may confound the assessments of injection pain.

Trial locations and contacts

1 site in 1 country.

United States1 site

Lotus Clinical Research, LLC
Pasadena, California, 91105

Other trials in United States

About this study

Official title: A Phase III, Single-Center, Open-labeled, Randomized Controlled Study Assessing Injection Pain of Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women

Conditions: Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women
Being tested: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

What participants receive

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

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)Drug
Also called Makena SQ
Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)Drug
Also called Makena

Study groups in NCT02937766
Study group	Role	What they receive
Treatment A	Experimental	Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) Receives: Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Treatment B	Active comparator	Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections) Receives: Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

What is being measured

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

Comparison of Average Pain Intensity
Comparison of average pain intensity associated with the administration of Makena® via subcutaneous autoinjector versus intramuscular injection (averaged over 4 visits).
Score on a scale: 0 (No Pain) up to 10 (Worst Pain Imaginable)
Measured: 4 weeks

Secondary outcomes (2)

Clinician Assessment of Ease of Injection Technique
Investigate the clinician's assessment of the ease of injection technique associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale.
Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3
Measured: 4 weeks
Clinician Assessment of Ease of Drug Preparation
Investigate the clinician's assessment of the ease of drug preparation associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale.
Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3
Measured: 4 weeks

Timeline

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

7 Oct 201627 Mar 2017

First posted19 Oct 2016 (estimated)
Study start7 Oct 2016
Primary completion6 Jan 2017
Study completion27 Mar 2017

Why it stopped: The Sponsor elected to discontinue the study prematurely due to business reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal WomenStudies 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02937766
Sponsor's protocol ID: AMAG-HPC-HPM-301
Status last verified: Mar 2022
First submitted: 17 Oct 2016
Last updated: 21 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Single-Center, Open-labeled, Randomized Controlled Study Assessing Injection Pain of Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women
ClinicalTrials.gov ID: NCT02937766
Acronym / sponsor ID: AMAG-HPC-HPM-301
Conditions: Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The Sponsor elected to discontinue the study prematurely due to business reasons
Enrolment: 60 participants (actual)
Lead sponsor: AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 7 Oct 2016 (actual)
Primary completion: 6 Jan 2017 (actual)
Study completion: 27 Mar 2017 (actual)
First posted: 19 Oct 2016 (estimated)
Results: Posted 12 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment A	Experimental	Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)
Treatment B	Active comparator	Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)

Who may qualify

Ages: 50 to 75 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Female subjects aged 50 to 75 years of age, inclusive, at Screening Visit.
Follicle stimulating hormone (FSH) levels greater than 40 mIU/mL.
Naturally or surgically postmenopausal with or without an intact uterus.

Key exclusion criteria (15 listed)

Have history of or positive test results for HIV or hepatitis B or C.
A significant history or current evidence of chronic infectious disease, organ dysfunction especially cardiovascular, renal, or hepatic disorders or other medical condition.
Receiving or have received chronic opioid therapy within 12 months.
Unwilling to stop taking/using:
History of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse in the last 12 months.

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
Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)Also: Makena SQ	Drug	Treatment A
Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)Also: Makena	Drug	Treatment B

Primary outcome

Comparison of Average Pain Intensity
Time frame: 4 weeks
Comparison of average pain intensity associated with the administration of Makena® via subcutaneous autoinjector versus intramuscular injection (averaged over 4 visits). Score on a scale: 0 (No Pain) up to 10 (Worst Pain Imaginable)

2 secondary outcomes

Clinician Assessment of Ease of Injection Technique
Time frame: 4 weeks
Clinician Assessment of Ease of Drug Preparation
Time frame: 4 weeks

Results and safety

Results posted to the registry on 12 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A	30	23
Treatment B	30	30

Primary outcome: Comparison of Average Pain Intensity

Time frame: 4 weeks. Number. Unit: Participants with Injection Site Pain

Measure	Treatment A n = 30	Treatment B n = 30
Value	3	2

Population analysed: The Comparison of Average Pain Intensity outcome was not analyzed. Pain assessments for participants included Adverse Events of Injection Site Pain reporting. 3 participants in Treatment Group A and 2 participants in Treatment Group B reported Injection Site Pain.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 66 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	1 of 30 (3.3%)	17 of 30 (56.7%)	Not reported
Treatment B	0 of 30 (0%)	13 of 30 (43.3%)	Not reported

Limitations and caveats (from the sponsor): The Sponsor elected to discontinue the study prematurely due to business reasons. The only parameters analyzed for efficacy were Ease of Drug Preparation and Ease of Injection Technique.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Neil Singla, MD principal investigator

Lotus Clinical Research, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 15 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 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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?

Yes. Results are posted in the registry (first posted 12 Dec 2018). 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?

Comparison of Average Pain Intensity (time frame: 4 weeks). 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 NCT02937766.

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 21 Apr 2022.