Trial Outcomes & Findings for Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT (NCT NCT01672801)

Last Updated: 2020-08-11

Results Overview

Compare the change between placebo treated and nimodipine treated patients by the presence or absence of an LH surge on intervention Day 1 and Day 2. LH surge will be determined by serum LH levels at least two times the baseline serum LH (baseline serum LH = (cycle day 3 serum \[LH\] + cycle day 7 serum \[LH\])/2).

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

7 days

Results posted on

2020-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Placebo comparator subjects will receive 8 total doses of liquid placebo orally 4 times a day for 8 total doses in pre-filled liquid placebo containing syringes Placebo: oral administration	Nimodipine All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Active comparator subjects will receive Nimodipine 30mg liquid orally 4 times a day for 8 total doses in pre-filled syringes Nimodipine: oral administration
Overall Study STARTED	9	9
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Placebo comparator subjects will receive 8 total doses of liquid placebo orally 4 times a day for 8 total doses in pre-filled liquid placebo containing syringes Placebo: oral administration	Nimodipine All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Active comparator subjects will receive Nimodipine 30mg liquid orally 4 times a day for 8 total doses in pre-filled syringes Nimodipine: oral administration
Overall Study Screen Failure	0	1

Baseline Characteristics

Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=9 Participants All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Placebo comparator subjects will receive 8 total doses of liquid placebo orally 4 times a day for 8 total doses in pre-filled liquid placebo containing syringes Placebo: oral administration	Nimodipine n=9 Participants All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Active comparator subjects will receive Nimodipine 30mg liquid orally 4 times a day for 8 total doses in pre-filled syringes Nimodipine: oral administration	Total n=18 Participants Total of all reporting groups
Age, Continuous	33 years n=99 Participants	37 years n=107 Participants	35 years n=206 Participants
Sex: Female, Male Female	9 Participants n=99 Participants	9 Participants n=107 Participants	18 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	8 Participants n=99 Participants	9 Participants n=107 Participants	17 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Placebo comparator subjects will receive 8 total doses of liquid placebo orally 4 times a day for 8 total doses in pre-filled liquid placebo containing syringes Placebo: oral administration	Nimodipine n=9 Participants All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Active comparator subjects will receive Nimodipine 30mg liquid orally 4 times a day for 8 total doses in pre-filled syringes Nimodipine: oral administration
LH Surge	9 Participants	9 Participants

SECONDARY outcome

Timeframe: Starting day 0 of intervention to pregnancy test (approximately 15 days)

Medication side effect profile including: symptomatic hypotension (Note: vital signs will be recorded), symptomatic tachycardia (Note: vital signs will be recorded), headache, nausea. These will be self-reported with constructed questionnaire.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Placebo comparator subjects will receive 8 total doses of liquid placebo orally 4 times a day for 8 total doses in pre-filled liquid placebo containing syringes Placebo: oral administration	Nimodipine n=9 Participants All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Active comparator subjects will receive Nimodipine 30mg liquid orally 4 times a day for 8 total doses in pre-filled syringes Nimodipine: oral administration
Number of Participants Experiencing Side Effects	3 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Intervention day 0 to ovulation (approximately 1-7 days)

Calculated changes in serum LH, FSH, and estradiol levels between patients in nimodipine and placebo arms

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Nimodipine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=9 participants at risk All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Placebo comparator subjects will receive 8 total doses of liquid placebo orally 4 times a day for 8 total doses in pre-filled liquid placebo containing syringes Placebo: oral administration	Nimodipine n=9 participants at risk All subjects in both arms will receive Clomid 100 mg tablets by mouth for 5 days prior to receiving either placebo comparator or active comparator. Active comparator subjects will receive Nimodipine 30mg liquid orally 4 times a day for 8 total doses in pre-filled syringes Nimodipine: oral administration
General disorders headache	22.2% 2/9 • Number of events 2	33.3% 3/9 • Number of events 3
General disorders Dizziness	0.00% 0/9	33.3% 3/9 • Number of events 3
General disorders Acne	22.2% 2/9 • Number of events 2	22.2% 2/9 • Number of events 2

Additional Information

Alan Penzias

Boston IVF

Phone: 781-434-6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place