Trial Outcomes & Findings for Sex Hormones and Orthostatic Tolerance (NCT NCT01153581)

Last Updated: 2018-12-13

Results Overview

We used a measure called cumulative stress index to determine orthostatic tolerance, which is the amount of time at a level of negative pressure each subject can maintain before feeling as if she is going to pass out. This is calculated by multiplying the pressure in mm Hg by the time in min.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

109 participants

Primary outcome timeframe

2 months

Results posted on

2018-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Women With and Without Orthostatic Intolerance Estrogen and Progesterone 17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills 17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day
Overall Study STARTED	109
Overall Study COMPLETED	109
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex Hormones and Orthostatic Tolerance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women n=109 Participants Estrogen and Progesterone 17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills 17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	109 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	22 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Outcome measures

Outcome measures
Measure	Women With and Without Orthostatic Intolerance n=109 Participants Estrogen and Progesterone 17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills 17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day	High Orthostatic Tolerant Women who can tolerate posture changes
Orthostatic Tolerance	634 mmHg*min Standard Deviation 213	—

PRIMARY outcome

Timeframe: 2 months

Population: Women with low and high orthostatic tolerance

This is a measure of how the body responds to changes in pressure induced by changes in position such as sitting, lying standing. The pressure changes are induced by gravity. The measurement described below to assess baroreceptor function is units of change in forearm vascular resistance for a given change in lower body negative pressure. This allows us to determine how good the body is at sending signals to the periphery to respond to postural changes. Baroreflex sensitivity is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg.

Outcome measures

Outcome measures
Measure	Women With and Without Orthostatic Intolerance n=7 Participants Estrogen and Progesterone 17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills 17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day	High Orthostatic Tolerant n=7 Participants Women who can tolerate posture changes
Baroreceptor Function	0.140 ms/mm Hg Standard Error 0.034	0.128 ms/mm Hg Standard Error 0.044

PRIMARY outcome

Timeframe: 2 months

Population: Women with and without orthostatic intolerance

Changes in blood flow in the small vessel in the skin are measured in response to sequential heat and drug stimulation. It is measured in volts, and then corrected for a maximum level and expressed as "% max." This is measured with a Laser Doppler probes, which measures volts.

Outcome measures

Outcome measures
Measure	Women With and Without Orthostatic Intolerance n=8 Participants Estrogen and Progesterone 17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills 17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day	High Orthostatic Tolerant n=8 Participants Women who can tolerate posture changes
Skin Microvascular Responses	4.02 Percent of max volts Standard Error 0.39	5.18 Percent of max volts Standard Error 0.31

Adverse Events

Ganirelix Acetate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

17β-Oestradiol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Progesterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nina Stachenfeld

Yale School of Medicine

Phone: 203-562-9901

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER