Trials Sponsors Conditions Drugs Pricing

Conditions

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

Outcome Measures

Primary Outcomes (1)

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)
4 weeks

Secondary Outcomes (2)

Clinician Assessment of Ease of Injection Technique
4 weeks
Clinician Assessment of Ease of Drug Preparation
4 weeks

Study Arms (2)

Treatment A

EXPERIMENTAL

Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)

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)

Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Interventions

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

Also known as: Makena SQ

Treatment A

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

Also known as: Makena

Treatment B

Eligibility Criteria

Age50 Years - 75 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Female subjects aged 50 to 75 years of age, inclusive, at Screening Visit.
Follicle stimulating hormone (FSH) levels greater than 40 mIU/mL.

Sponsors & Collaborators

AMAG Pharmaceuticals, Inc.
Industrylead

Study Sites (1)

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

MeSH Terms

Interventions

17 alpha-Hydroxyprogesterone Caproate

Intervention Hierarchy (Ancestors)

17-alpha-HydroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsProgesterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

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.

Results Point of Contact

Title: Medical Information
Organization: AMAG Pharmaceuticals, Inc.

Study Officials

Neil Singla, MD
Lotus Clinical Research, LLC
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

60 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 19, 2016

Study Start

October 7, 2016

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Treatment A

Treatment B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Treatment A

Treatment B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations