Trial Outcomes & Findings for Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women (NCT NCT01126801)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

one month

Results posted on

2017-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Estradiol Estradiol: Oral estradiol 1.0 mg/day for four weeks.	Placebo Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Estradiol n=1 Participants Estradiol: Oral estradiol 1.0 mg/day for four weeks.	Placebo n=1 Participants Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.	Total n=2 Participants Total of all reporting groups
Age, Continuous	50 years STANDARD_DEVIATION 0 • n=5 Participants	55 years STANDARD_DEVIATION 0 • n=7 Participants	52.5 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: one month

Population: No participants were analyzed since the study was terminated due to difficulty recruiting subjects. Because data from only one subject per arm were collected, these data are not reported to preserve subject privacy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one month

Population: No participants were analyzed since the study was terminated due to difficulty recruiting subjects. Because data from only one subject per arm were collected, these data are not reported to preserve subject privacy.

Outcome measures

Outcome data not reported

Adverse Events

Estradiol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Hadine Joffe

Brigham & Women's Hospital

Phone: 617-732-4906

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place