Trial Outcomes & Findings for Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation (NCT NCT01291056)

Results Overview

To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

1 year

Results posted on

2016-06-28

Participant Flow

Eligible participants were identified by physicians at the Utah Center for Reproductive Medicine at the University of Utah and provided written informed consent before being randomized to treatment groups.

Participant milestones

Participant milestones
Measure	Clomiphene Citrate, Then Placebo Clomiphene Citrate 50 milligrams daily, then Placebo daily	Placebo, Then Clomiphene Citrate Placebo, then Clomiphene Citrate 50 milligrams daily
Intervention One (Menstraution Day 3-7) STARTED	10	10
Intervention One (Menstraution Day 3-7) COMPLETED	10	10
Intervention One (Menstraution Day 3-7) NOT COMPLETED	0	0
Washout STARTED	10	10
Washout COMPLETED	10	10
Washout NOT COMPLETED	0	0
Intervention Two (Menstration Days 3-7) STARTED	10	10
Intervention Two (Menstration Days 3-7) COMPLETED	10	10
Intervention Two (Menstration Days 3-7) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clomiphene Citrate, Then Placebo n=10 Participants Clomiphene Citrate 50 milligrams daily, then Placebo daily	Placebo, Then Clomiphene Citrate n=10 Participants Placebo, then Clomiphene Citrate 50 milligrams daily	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.

To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.

Outcome measures

Outcome measures
Measure	Clomiphene Citrate n=20 Participants Clomiphene Citrate 50 milligrams daily	Placebo n=20 Participants Placebo
Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment	3 units on a scale Interval 0.0 to 6.0	5 units on a scale Interval 1.0 to 18.0

PRIMARY outcome

Timeframe: 1 Year

Population: The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.

To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.

Outcome measures

Outcome measures
Measure	Clomiphene Citrate n=20 Participants Clomiphene Citrate 50 milligrams daily	Placebo n=20 Participants Placebo
Follicular Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment	10 units on a scale Interval 2.25 to 14.0	8 units on a scale Interval 5.0 to 26.0

PRIMARY outcome

Timeframe: 1 year

Population: The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.

To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.

Outcome measures

Outcome measures
Measure	Clomiphene Citrate n=20 Participants Clomiphene Citrate 50 milligrams daily	Placebo n=20 Participants Placebo
Luteal Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment	5 units on a scale Interval 0.0 to 14.5	2 units on a scale Interval 0.0 to 13.0

PRIMARY outcome

Timeframe: 1 year

Population: The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Physical symptoms were calculated to give the total score. Range 0 -75 per cycle day.

To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.

Outcome measures

Outcome measures
Measure	Clomiphene Citrate n=20 Participants Clomiphene Citrate 50 milligrams daily	Placebo n=20 Participants Placebo
Luteal Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment	9 units on a scale Interval 3.25 to 15.0	9 units on a scale Interval 0.0 to 28.0

Adverse Events

Clomiphene Citrate, Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo, Then Clomiphene Citrate

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. Jessica Pittman

University of Utah Department of Obstetrics & Gynecology

Phone: 801-339-4103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place