Trial Outcomes & Findings for DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding (NCT NCT01148420)

Results Overview

Patients were called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they msy have been experiencing. Patients were asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who were still having any bleeding on day 3 were contacted on day 5

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

48 participants

Primary outcome timeframe

3-5 days

Results posted on

2014-03-13

Participant Flow

Participants were recruited from the GYN clinic at the Harbor-UCLA Medical Center.

Women were excluded if they were pregnant, hemodynamically unstable, had a known endometrial or cervical carcinoma, required immediate surgery, had hemoglobin less than 8, or had failed an earlier hormonal treatment for the current episode of bleeding.

Participant milestones

Participant milestones
Measure	DMPA + MPA 150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DMPA + MPA n=48 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	40.7 years STANDARD_DEVIATION 9.35 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants
BMI	34.9 kg/m^2 STANDARD_DEVIATION 8.09 • n=5 Participants
Hemoglobin baseline	10.9 g/dL STANDARD_DEVIATION 1.58 • n=5 Participants

PRIMARY outcome

Timeframe: 3-5 days

Patients were called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they msy have been experiencing. Patients were asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who were still having any bleeding on day 3 were contacted on day 5

Outcome measures

Outcome measures
Measure	DMPA + MPA n=48 Participants 150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
Cessation of Bleeding Within 5 Days	48 participants

SECONDARY outcome

Timeframe: End of the trial; up to day 5

Results from a survey question that assessed the subjects' satisfaction with the therapy on a scale of 1-3. 1 = poor; 2 = good; 3 = excellent.

Outcome measures

Outcome measures
Measure	DMPA + MPA n=48 Participants 150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
Patient Perception of the Acceptability of the Treatment	3 units on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: End of the trial; up to day 5

Participants were asked whether they would recommend this treatment to a friend

Outcome measures

Outcome measures
Measure	DMPA + MPA n=48 Participants 150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
Satisfaction and Willingness to Recommend Treatment Participants who would recommend this treatment	48 participants
Satisfaction and Willingness to Recommend Treatment Participants who would not recommend it	0 participants

Adverse Events

DMPA & High Dose MPA

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DMPA & High Dose MPA n=48 participants at risk DMPA \& High Dose MPA
Reproductive system and breast disorders Bloating	14.6% 7/48 • Five days
Reproductive system and breast disorders Fatigue	12.5% 6/48 • Five days
Reproductive system and breast disorders Cramping	6.2% 3/48 • Five days
Reproductive system and breast disorders Mood changes	4.2% 2/48 • Five days
Reproductive system and breast disorders Nausea	2.1% 1/48 • Five days
Reproductive system and breast disorders Increased appetite	2.1% 1/48 • Five days
Reproductive system and breast disorders Bone Pain	2.1% 1/48 • Five days

Additional Information

Anita Nelson

Harbor - UCLA Medical Center

Phone: 310-222-3871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place