Trial Outcomes & Findings for Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone (NCT NCT01428193)

Last Updated: 2018-06-04

Results Overview

The primary outcome variable for the study is the slope of the percent change in LH pulses as a function of day 7 progesterone level.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

3 weeks after flutamide treatment

Results posted on

2018-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	Flutamide, Estrace, Progesterone For flutamide, subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day for approximately 3 weeks. Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission. Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission. Flutamide: Subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day. Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days estrace: 0.5-1 mg once a day for seven days
Overall Study STARTED	4
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Flutamide, Estrace, Progesterone For flutamide, subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day for approximately 3 weeks. Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission. Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission. Flutamide: Subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day. Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days estrace: 0.5-1 mg once a day for seven days
Overall Study Physician Decision	1
Overall Study Elevated screening liver enzymes	1

Baseline Characteristics

Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flutamide, Estrace, Progesterone n=4 Participants For flutamide, subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day for approximately 3 weeks. Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission. Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission. Flutamide: Subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day. Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days estrace: 0.5-1 mg once a day for seven days
Age, Categorical <=18 years	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	15.5 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks after flutamide treatment

Population: One subject completed the study but had not taken the study medication so her data is unusable. The second subject completed the study. However, no data were formally analyzed. We were subsequently unable to recruit any additional subjects.

The primary outcome variable for the study is the slope of the percent change in LH pulses as a function of day 7 progesterone level.

Outcome measures

Outcome measures
Measure	Flutamide, Estrace, Progesterone n=1 Participants For flutamide, subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day for approximately 3 weeks. Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission. Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission. Flutamide: Subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day. Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days estrace: 0.5-1 mg once a day for seven days
Slope of the Percent Change in Luteinizing Hormone (LH) Pulses as a Function of Day 7 Progesterone Level	-0.55 percentage of slope change

Adverse Events

Flutamide, Estrace, Progesterone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Flutamide, Estrace, Progesterone n=4 participants at risk For flutamide, subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day for approximately 3 weeks. Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission. Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission. Flutamide: Subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day. Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days estrace: 0.5-1 mg once a day for seven days
Social circumstances Mood change, sadness	25.0% 1/4 • Two weeks post study drug intervention, at time of last blood draw.

Additional Information

Clinical Research Coordinator

University of Virginia

Phone: 434-243-6911

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place