- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01859312
Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia
A Pilot Study Assessing the Use of Continuous Subcutaneous Hydrocortisone Infusion in the Treatment of Congenital Adrenal Hyperplasia
Background:
- Congenital adrenal hyperplasia (CAH) is a genetic disorder of the adrenal gland. The adrenal gland is located in the abdomen and produces small amounts of hormones such as cortisol, aldosterone, and androgen. These hormones help control blood pressure, protect the body, and maintain good health, especially during development. People with CAH do not make enough cortisol and aldosterone, and make too much androgen. This can lead to serious medical problems. The standard treatment is to take pills that mimic the effects of cortisol and aldosterone. However, treatment with pills can have long-term side effects because of the higher doses needed, and may not work well for some people.
- A possible new treatment for CAH is to use a pump to deliver cortisol under the skin. Similar pumps are often used to give insulin to people with diabetes. Researchers think that a cortisol pump might be able to help the body use the cortisol more effectively than taking pills. They want to compare the results of a cortisol pump and standard pill treatments for CAH.
Objectives:
- To compare the effectiveness of a cortisol pump with standard cortisol pill therapy for CAH.
Eligibility:
- Men and women at least 18 years of age who have CAH (see more details in Eligibility section below).
Design:
- This study will involve four inpatient hospital stays at the National Institutes of Health in Bethesda, MD over 6 months (spaced 2 months apart). The first and last stays will last about 5 days. The second and third stays will last about 3 days.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- At the first study visit, participants will provide regular blood and urine samples. They will also have imaging studies. These studies will look at the bones, fat, and muscles in the abdomen and pelvis.
- Participants will receive a cortisol pump during the first visit. They will be shown how to use the pump. They will also learn what to do, if they need to take extra "stress dose" cortisol pills.
- At the second and third visits, the cortisol dose given with the pump will be adjusted as needed. Blood and urine samples will also be collected. No imaging studies are scheduled for these visits.
- The last study visit will have the same tests as the first visit. Participants will be offered the chance to continue with the pump treatment for 1 more year, or go back to their standard pill treatment.
Study type: Interventional non-randomized trial
Official title: A Pilot Study Assessing the use of Continuous Subcutaneous Hydrocortisone Infusion In the Treatment of Congenital Adrenal Hyperplasia
Estimated enrollment: 8
Study Start Date: May 2013
Estimated Study Completion Date: December 2016
Sponsoring Institute: National Institute of Child Health and Human Development
<TAB>ELIGIBILITY
Inclusion criteria
- Men and women 18 years of age or older with classic congenital adrenal hyperplasia (21-Hydroxylase deficiency)
- High adrenal androgens in the blood, and
- One or more of the following conditions: obesity, fatty liver, risk for diabetes, low bone mass, inability to tolerate cortisol pills
Exclusion criteria
- Pregnancy
- Breast feeding
- Use of inhaled or oral steroids for diseases other than CAH
- Use of estrogen-containing birth control pills
- Use of medicines that cross-react with hydrocortisone
- Use of stress dose steroids for illness during the last 30 days prior to joining the study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
- Patients with known classic CAH due to 21-hydroxylase deficiency as evidenced by hormonal and genetic testing
- Male or female patients 18 years or older
- Females must have a negative pregnancy test initially and at all visits. Sexually active females must be using a medically acceptable method of contraception.
- Patients with elevated adrenal androgens (defined as 17-OHP >1200 ng/dL and androstenedione >210 ng/dL)
- One or more co-morbidities:<TAB>
- Obesity [body mass index (BMI) greater than 30.0 kg/m(2)]
- Fatty liver disease; assessed by AST/ALT liver enzyme ratio (AST to ALT ratio <1 (11)) liver ultrasound or MRI imaging (Steatosis score as previously described)
- Low insulin sensitivity; assessed by the Homeostasis Model Assessment Insulin Resistance (HOMA-IR) method [HOMA-IR = insulin (micro U/ml) times glucose (mmol/L)/ 22.5]. Elevated HOMA-IR index is defined as >2.6 in adults17.
- Osteopenia [bone mineral density by DEXA (at the spine, hip, or forearm) with T-score of -1 to -2.5) or osteoporosis (bone mineral density by DEXA (at the spine, hip, or forearm) with T-score of <-2.5] defined according to World Health Organization (WHO).
- Glucocorticoid-related gastrointestinal side effects (nausea, vomiting, dyspepsia, anorexia, gastritis, peptic ulcer disease and gastric bleeding)
EXCLUSION CRITERIA:
- Co-morbid conditions requiring daily administration of medications that induce hepatic enzymes or interfere with the metabolism of glucocorticoids
- Females who are pregnant or lactating
- Patients on inhaled or oral steroids given for reasons other than treatment of CAH
- Women who have taken estrogen-containing oral contraceptive pills within 6 weeks of recruitment
- Patients who required stress dose glucocorticoids for an illness within 4 weeks of recruitment
- Patients who changed their glucocorticoid agent within 3 months of recruitment
- Patients who underwent bilateral adrenalectomy
- Co-morbid conditions that could interfere with the ability to comply to the protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Continuous Subcutaneous Hydrocortisone Infusion
Enrolled participants with congenital adrenal hyperplasia (CAH) received continuous subcutaneous hydrocortisone (Solucortef) infusion (CSHI) via insulin pump (Medtronic) (MMT-722Na) to achieve near-physiologic cortisol replacement therapy.
Participants were their own controls; participant's baseline outcomes/lab values while on conventional glucocorticoid therapy were compared to outcomes/lab values after 6 months of treatment using CSHI via insulin pump.
|
Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA).
Total daily hydrocortisone dose was calculated based on the patient's estimated cortisol clearance.
Rates were established to achieve peak and trough concentrations within the normal circadian cortisol range.
Other Names:
Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With 17-OHP Levels Equal or Below 1,200 ng/dL at 0700
Time Frame: At baseline
|
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
|
At baseline
|
Number of Patients With 17-OH Progesterone Levels Equal or Below 1,200 ng/dL at 0700
Time Frame: At 6 months
|
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
|
At 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants Mean Level of 17-OHP at 0700
Time Frame: At baseline
|
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
|
At baseline
|
Participants Mean Level of 17-OHP at 0700
Time Frame: At 6 months
|
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency
|
At 6 months
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours
Time Frame: At baseline
|
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.
AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours
Time Frame: At 6 months
|
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.
AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)
Time Frame: At baseline
|
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)
Time Frame: At 6 months
|
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)
Time Frame: At baseline
|
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficienc.
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)
Time Frame: At 6 months
|
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Time Frame: At baseline
|
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Time Frame: At 6 months
|
17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of Androstenedione at 0700
Time Frame: At baseline
|
Participants Mean Level of Androstenedione at 0700.
|
At baseline
|
Participants Mean Level of Androstenedione at 0700
Time Frame: At 6 months
|
Participants Mean Level of Androstenedione at 0700.
|
At 6 months
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours
Time Frame: At baseline
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 hours.
AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours
Time Frame: At 6 months
|
Participants Mean Level of Androstenedione area under the curve (AUC) - 24 hours.
AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)
Time Frame: At baseline
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)
Time Frame: At 6 months
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)
Time Frame: At baseline
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)
Time Frame: At 6 months
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Time Frame: At baseline
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Time Frame: At 6 months
|
Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of ACTH at 0700
Time Frame: At baseline
|
Participants Mean Level of ACTH at 0700.
|
At baseline
|
Participants Mean Level of ACTH at 0700
Time Frame: At 6 months
|
Participants Mean Level of ACTH at 0700.
|
At 6 months
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours
Time Frame: At baseline
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours.
AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours
Time Frame: At 6 months
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours.
AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)
Time Frame: At baseline
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)
Time Frame: At 6 months
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)
Time Frame: At baseline
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)
Time Frame: At 6 months
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Time Frame: At baseline
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Time Frame: At 6 months
|
Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Progesterone Levels at 0700
Time Frame: At baseline
|
Participants Mean Level of Progesterone at 0700
|
At baseline
|
Participants Mean Progesterone Level at 0700
Time Frame: At 6 months
|
Participants Mean Level of Progesterone at 0700
|
At 6 months
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours
Time Frame: At baseline
|
Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours.
AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours
Time Frame: At 6 months
|
Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours.
AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)
Time Frame: At baseline
|
Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)
Time Frame: At 6 months
|
Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)
Time Frame: At baseline
|
Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)
Time Frame: At 6 months
|
Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Time Frame: At baseline
|
Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At baseline
|
Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)
Time Frame: At 6 months
|
Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700).
AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700.
Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).
|
At 6 months
|
Participant Lean Body Mass
Time Frame: At baseline
|
lean body mass measured by DEXA, Hologic Discovery-A
|
At baseline
|
Participant Lean Body Mass
Time Frame: At 6 months
|
lean body mass measured by DEXA, Hologic Discovery-A
|
At 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Deborah P Merke, M.D., National Institutes of Health Clinical Center (CC)
Publications and helpful links
General Publications
- Debono M, Ghobadi C, Rostami-Hodjegan A, Huatan H, Campbell MJ, Newell-Price J, Darzy K, Merke DP, Arlt W, Ross RJ. Modified-release hydrocortisone to provide circadian cortisol profiles. J Clin Endocrinol Metab. 2009 May;94(5):1548-54. doi: 10.1210/jc.2008-2380. Epub 2009 Feb 17.
- Finkielstain GP, Kim MS, Sinaii N, Nishitani M, Van Ryzin C, Hill SC, Reynolds JC, Hanna RM, Merke DP. Clinical characteristics of a cohort of 244 patients with congenital adrenal hyperplasia. J Clin Endocrinol Metab. 2012 Dec;97(12):4429-38. doi: 10.1210/jc.2012-2102. Epub 2012 Sep 18.
- Arlt W, Willis DS, Wild SH, Krone N, Doherty EJ, Hahner S, Han TS, Carroll PV, Conway GS, Rees DA, Stimson RH, Walker BR, Connell JM, Ross RJ; United Kingdom Congenital Adrenal Hyperplasia Adult Study Executive (CaHASE). Health status of adults with congenital adrenal hyperplasia: a cohort study of 203 patients. J Clin Endocrinol Metab. 2010 Nov;95(11):5110-21. doi: 10.1210/jc.2010-0917. Epub 2010 Aug 18.
- Nella AA, Mallappa A, Perritt AF, Gounden V, Kumar P, Sinaii N, Daley LA, Ling A, Liu CY, Soldin SJ, Merke DP. A Phase 2 Study of Continuous Subcutaneous Hydrocortisone Infusion in Adults With Congenital Adrenal Hyperplasia. J Clin Endocrinol Metab. 2016 Dec;101(12):4690-4698. doi: 10.1210/jc.2016-1916. Epub 2016 Sep 28.
- Mallappa A, Nella AA, Sinaii N, Rao H, Gounden V, Perritt AF, Kumar P, Ling A, Liu CY, Soldin SJ, Merke DP. Long-term use of continuous subcutaneous hydrocortisone infusion therapy in patients with congenital adrenal hyperplasia. Clin Endocrinol (Oxf). 2018 Oct;89(4):399-407. doi: 10.1111/cen.13813. Epub 2018 Aug 8.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Endocrine System Diseases
- Gonadal Disorders
- Disorders of Sex Development
- Urogenital Abnormalities
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Adrenal Gland Diseases
- Steroid Metabolism, Inborn Errors
- Hyperplasia
- Adrenal Hyperplasia, Congenital
- Adrenogenital Syndrome
- Adrenocortical Hyperfunction
- Adrenal Insufficiency
- Anti-Inflammatory Agents
- Hydrocortisone
- Hydrocortisone hemisuccinate
Other Study ID Numbers
- 130121
- 13-CH-0121 (Other Identifier: National Institute of Child Health and Human Development)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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Clinical Trials on Adrenal Insufficiency
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University Hospital TuebingenCompletedAdrenal InsufficiencyGermany
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Assistance Publique - Hôpitaux de ParisNot yet recruitingGlucocorticoid-induced Adrenal InsufficiencyFrance
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Tobias ElseCorcept TherapeuticsTerminatedMifepristone | Central Adrenal InsufficiencyUnited States
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Assistance Publique Hopitaux De MarseilleTerminatedAdrenocortical InsufficiencyFrance
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Diurnal LimitedActive, not recruitingPrimary Adrenal InsufficiencyGermany, United Kingdom
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University of Roma La SapienzaCompletedSecondary Adrenal Insufficiency | Primary Adrenal InsufficiencyItaly
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Chronic Obstructive Pulmonary Disease Trial Network...Rigshospitalet, DenmarkCompleted
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Bruno AllolioCompletedPrimary Adrenal InsufficiencyGermany
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University of BergenKarolinska Institutet; Charite University, Berlin, GermanyActive, not recruitingPrimary Adrenal InsufficiencyNorway, Sweden, Germany
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University Medical Center GroningenCompletedAdrenal InsufficiencyNetherlands
Clinical Trials on Hydrocortisone (Solucortef)
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University of AthensUniversity of ThessalyCompletedInfections | Cardiac ArrestFrance, Greece
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Universitaire Ziekenhuizen KU LeuvenTerminatedLiver CirrhosisSpain, United Kingdom, Denmark, Germany, Czechia, Belgium, Italy
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Community Medical Center, Toms River, NJCompletedSeptic Shock | Sepsis, SevereUnited States
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University of AthensUniversity of ThessalyCompleted
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Assistance Publique - Hôpitaux de ParisCompletedBronchopulmonary DysplasiaFrance
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Horus UniversityRecruitingSubacromial Impingement Syndrome | Impingement SyndromeEgypt
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University Hospital Southampton NHS Foundation...Imperial College London; University of Bristol; University Hospitals Bristol... and other collaboratorsCompleted
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University of VersaillesAssistance Publique - Hôpitaux de ParisTerminatedPneumonia, Viral | Influenza in HumansFrance
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Ulla Feldt-RasmussenUnknown