Trial Outcomes & Findings for Treatment of Menorrhagia in Women With Thrombocytopenia Using Platelets or Platelets and Hormones (NCT NCT00556400)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

1 week

Results posted on

2013-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	Lo-ovral 1 tablet of lo-ovral is administered twice a day	Sugar Pill
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Menorrhagia in Women With Thrombocytopenia Using Platelets or Platelets and Hormones

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lo-ovral n=1 Participants 1 tablet of lo-ovral is administered twice a day	Sugar Pill	Total n=1 Participants Total of all reporting groups
Age Categorical <=18 years	1 participants n=99 Participants	—	1 participants n=206 Participants
Age Categorical Between 18 and 65 years	0 participants n=99 Participants	—	0 participants n=206 Participants
Age Categorical >=65 years	0 participants n=99 Participants	—	0 participants n=206 Participants
Gender Female	1 participants n=99 Participants	—	1 participants n=206 Participants
Gender Male	0 participants n=99 Participants	—	0 participants n=206 Participants
Region of Enrollment United States	1 participants n=99 Participants	—	1 participants n=206 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Population: Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 week

Population: Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Sugar Pill

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. Pamela Stratton

NICHD

Phone: 301 496-9079

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place