Trial Outcomes & Findings for Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome (NCT NCT00427700)

Results Overview

Ovulation detected by ultrasound was defined as the percentage of a participants with ovulation detected by ultrasound, defined as the dominant follicle and its subsequent collapse. If a dominant follicle was not observed by day 21 after menses, the ovulation induction was considered to be a failure.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

82 participants

Primary outcome timeframe

cycle day 14-20

Results posted on

2024-08-21

Participant Flow

Recruitment occurred between September 2008 and October 2009 at Hospital de Clínicas de Porto Alegre, a tertiary teaching hospital.

Women were excluded if they had elevated levels of thyroid-stimulating hormone, prolactin, or 17α-hydroxyprogesterone, if they had used oral contraceptives in the previous 2 months, or if they had a history of endometriosis.

Participant milestones

Participant milestones
Measure	Clomiphene Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle	Raloxiphene Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
Overall Study STARTED	40	42
Overall Study COMPLETED	37	31
Overall Study NOT COMPLETED	3	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Clomiphene Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle	Raloxiphene Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
Overall Study Lost to Follow-up	2	5
Overall Study no induction of menses	1	4
Overall Study Pregnancy	0	2

Baseline Characteristics

Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Raloxifene n=42 Participants Use of 100mg of raloxifene during days 5-9 of the menstrual cycle raloxifene: 100mg PO on days 5-9 of the menstrual cycle	Clomiphene n=40 Participants Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle clomiphene citrate: 100mg PO on days 5-9 of the menstrual cycle	Total n=82 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	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.21 years STANDARD_DEVIATION 5.3 • n=5 Participants	28.7 years STANDARD_DEVIATION 4.8 • n=7 Participants	28.4 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Brazil	42 participants n=5 Participants	40 participants n=7 Participants	82 participants n=5 Participants

PRIMARY outcome

Timeframe: cycle day 14-20

Population: intention to treat.

Ovulation detected by ultrasound was defined as the percentage of a participants with ovulation detected by ultrasound, defined as the dominant follicle and its subsequent collapse. If a dominant follicle was not observed by day 21 after menses, the ovulation induction was considered to be a failure.

Outcome measures

Outcome measures
Measure	Clomiphene n=40 Participants Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle	Raloxifene n=42 Participants Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
Percentage of Participants With Ovulation Detected by Ultrasound	52.5 percentage of participants Interval 36.1 to 68.5	40.4 percentage of participants Interval 25.6 to 56.6

SECONDARY outcome

Timeframe: 8-10 days after ovulation

Population: Intention to treat.Cases that were lost to follow-up observation, dropped out of the study, failed to collect progesterone on days 22 to 24, and lacked menses after medroxyprogesterone acetate treatment were considered as failures according to the intention-to-treat analysis.

The level of serum progesterone that indicated ovulation was considered to be 3 ng/mL or greater, on days 8 to 10 after ovulation.

Outcome measures

Outcome measures
Measure	Clomiphene n=40 Participants Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle	Raloxifene n=42 Participants Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
Serum Levels of Progesterone	26.1 ng/mL Interval 13.8 to 42.0	40 ng/mL Interval 24.8 to 56.6

Adverse Events

Clomiphene Citrate

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Raloxifene

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Clomiphene Citrate n=40 participants at risk Use of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle clomiphene citrate: 100mg PO on days 5-9 of the menstrual cycle One woman in the CC group had nausea, headache, and abdominal bloating.	Raloxifene n=42 participants at risk Use of 100mg of raloxifene during days 5-9 of the menstrual cycle raloxifene: 100mg PO on days 5-9 of the menstrual cycle Two cases: one woman had nausea, and the other woman had nausea, headache, and pelvic pain. All mild
Gastrointestinal disorders nausea	2.5% 1/40 • Number of events 1 • 1 year	4.8% 2/42 • Number of events 2 • 1 year
Nervous system disorders headache	2.5% 1/40 • Number of events 1 • 1 year	2.4% 1/42 • Number of events 1 • 1 year
Gastrointestinal disorders abdominal bloating	2.5% 1/40 • Number of events 1 • 1 year	0.00% 0/42 • 1 year
Reproductive system and breast disorders pelvic pain	0.00% 0/40 • 1 year	2.4% 1/42 • Number of events 1 • 1 year

Additional Information

Dr. Ricardo Francalacci Savaris

Hospital de Clínicas de Porto Alege

Phone: 51 33598405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place