A comparison of 17 Hydroxyprogesterone hormone levels after injection of two formulations of Corticotropin injection

A comparison of Porcine Sequence Corticotropin to Tetracosactide Hexaacetate on stimulated 17 Hydroxyprogesterone levels in healthy individuals. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069346

Enrollment

Registered

2024-06-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Porcine Sequence Corticotropin: In every subject, Low dose Porcine sequence Corticotropin of 6 IU/62.5 µg (0.1 ml) will be given as intramuscular injection once. After gap of minimum 3

Eligibility

Inclusion criteria

Inclusion criteria: Healthy volunteers, aged between 18 to 60 years.

Exclusion criteria

Exclusion criteria: Known patients with adrenal insufficiency, Pregnant women, Aged 60 years.

Design outcomes

Primary

Measure	Time frame
To compare stimulated 17 hydroxyprogesterone response after low dose and standard dose injection Porcine sequence Corticotropin with stimulated 17 hydroxyprogesterone levels after standard dose injection Tetracosactide Hexaacetate in healthy individuals.Timepoint: 17 Hydroxyprogesterone will be estimated at baseline before each of the injections, followed by at 30 and 60 minutes after each injection. There will be gap of minimum 3 days between each injection administration.	—

Measure

Time frame

To compare stimulated 17 hydroxyprogesterone response after low dose and standard dose injection Porcine sequence Corticotropin with stimulated 17 hydroxyprogesterone levels after standard dose injection Tetracosactide Hexaacetate in healthy individuals.Timepoint: 17 Hydroxyprogesterone will be estimated at baseline before each of the injections, followed by at 30 and 60 minutes after each injection. There will be gap of minimum 3 days between each injection administration.

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Secondary

Measure	Time frame
To compare stimulated cortisol response after low dose & standard dose injection Porcine sequence Corticotropin with stimulated cortisol levels after standard dose of injection Tetracosactide Hexaacetate in healthy individuals.Timepoint: Serum cortisol will be estimated at baseline before each injection, followed by estimation at 30 & 60 minutes after each injection. There will be gap of minimum 3 days between each injection administration.	—

Measure

Time frame

To compare stimulated cortisol response after low dose & standard dose injection Porcine sequence Corticotropin with stimulated cortisol levels after standard dose of injection Tetracosactide Hexaacetate in healthy individuals.Timepoint: Serum cortisol will be estimated at baseline before each injection, followed by estimation at 30 & 60 minutes after each injection. There will be gap of minimum 3 days between each injection administration.

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Countries

India

Contacts

Public ContactSonali Appaiah

St Johns Medical College Hospital

Sonaliappaiah2@gmail.com9448490363

Outcome results