Trial Outcomes & Findings for The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass (NCT NCT01928082)

NCT ID: NCT01928082

Last Updated: 2018-12-10

Results Overview

0 participants were measured because the study was terminated

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

4 weeks, 8 weeks

Results posted on

2018-12-10

Participant Flow

Participant milestones

Participant milestones
Measure
Transdermal Estradiol
Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day
Overall Study
STARTED
1
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Transdermal Estradiol
Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day
Overall Study
Study terminated.
1

Baseline Characteristics

The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 4 weeks, 8 weeks

Population: 0 participants were analyzed because the study was terminated

0 participants were measured because the study was terminated

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks, 8 weeks

Population: The study was terminated

0 participants were analyzed because the study was terminated

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks, 8 weeks

Population: the study was terminated

Not available because the study was terminated

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks, 8 weeks

Population: Not available because the study was terminated

Not available because the study was terminated

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks, 8 weeks

Population: Not available because the study was terminated

Not available because the study was terminated

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks, 8 weeks

Population: Not available because the study was terminated

Not available because the study was terminated

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks, 8 weeks

Population: Not available because the study was terminated

Not available because the study was terminated

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks, 8 weeks

Population: Not available because the study was terminated

Not available because the study was terminated

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks, 8 weeks

Population: Not available because the study was terminated

Not available because the study was terminated

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks, 8 weeks

Population: Not available because the study was terminated

Not available because the study was terminated

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks, 8 weeks

Population: Not available because the study was terminated

Not available because the study was terminated

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks, 8 weeks

Population: Not available because the study was terminated

Not available because the study was terminated

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks, 8 weeks

Population: Not available because the study was terminated

Not available because the study was terminated

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks, 8 weeks

Population: Not available because the study was terminated

Not available because the study was terminated

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks, 8 weeks

Population: Not available because the study was terminated

It is not available because the study was terminated

Outcome measures

Outcome data not reported

Adverse Events

Transdermal Estradiol

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

Murray J. Favus

The University of Chicago

Phone: (773) 702-6138

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place