Trials Sponsors Conditions Drugs Pricing

Conditions

Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women

Outcome Measures

Primary Outcomes (2)

Comparison of Areas Under the Curve (AUC) to the Last Time With a Concentration ≥ LLOQ [AUC0-t] and to Infinity [AUCinf]
Comparison of areas under the curve (AUC) to the last time with a concentration ≥ LLOQ \[AUC0-t\] and to infinity \[AUCinf\] for the Primary PK Population
9 weeks
Comparison of the Maximum Plasma Concentration (Cmax)
Comparison of the maximum plasma concentration (Cmax) for the Primary PK Population
9 weeks

Secondary Outcomes (4)

Comparison of Tmax
9 weeks
Comparison of AUC (0-168)
9 weeks
Comparison of t1/2
9 weeks
Comparison of Elimination Rate Constant
9 weeks

Study Arms (2)

Treatment A

EXPERIMENTAL

Subcutaneous (SQ) injection using an autoinjector

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

Treatment B

ACTIVE COMPARATOR

Intramuscular injection (IM) using syringe and needle

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:

\. Naturally or surgically postmenopausal women, with or without an intact uterus, aged 50 to 75 years of age, inclusive. FSH levels greater than 40 mIU/mL

You may not qualify if:

Sponsors & Collaborators

AMAG Pharmaceuticals, Inc.
Industrylead

Study Sites (5)

Anaheim, California, 92801, United States

DeLand, Florida, 32720, United States

Miami, Florida, 33143, United States

Orlando, Florida, 32809, United States

San Antonio, Texas, 78209, United States

Related Publications (1)

Krop J, Kramer WG. Comparative Bioavailability of Hydroxyprogesterone Caproate Administered via Intramuscular Injection or Subcutaneous Autoinjector in Healthy Postmenopausal Women: A Randomized, Parallel Group, Open-label Study. Clin Ther. 2017 Dec;39(12):2345-2354. doi: 10.1016/j.clinthera.2017.10.020. Epub 2017 Nov 27.
PMID: 29191450DERIVED

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

Results Point of Contact

Title: Medical Information
Organization: AMAG Pharmaceuticals, Inc.

Study Officials

Julie Krop, MD
AMAG Pharmaceuticals, Inc.
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

122 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
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 21, 2016

Study Start

September 2016

Actual (reported)

Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector 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 (2)

Secondary Outcomes (4)

Study Arms (2)

Treatment A

Treatment B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

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 (2)

Secondary Outcomes (4)

Study Arms (2)

Treatment A

Treatment B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations