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Trial Outcomes & Findings for Clomiphene Citrate for Treatment of Acromegaly (NCT NCT02274311)

NCT ID: NCT02274311

Last Updated: 2019-05-07

Results Overview

The objective is to compare the change of IGF-1 value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Day 90

Results posted on

2019-05-07

Participant Flow

Acromegalic patients with uncontrolled hormonal levels despite current medical treatment

Patients should be on stable medical treatment for at least 6 months prior entering the study. Patients submitted to radiotherapy in the last 10 years were not eligible.

Participant milestones

Participant milestones
Measure
Clomiphene Citrate
Patients receiving clomiphene citrate Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months 16 patients were enrolled
Three Months of Clomiphene Treatment
STARTED
16
Three Months of Clomiphene Treatment
COMPLETED
16
Three Months of Clomiphene Treatment
NOT COMPLETED
0
Three Months of Clomiphene Wash-out
STARTED
16
Three Months of Clomiphene Wash-out
COMPLETED
15
Three Months of Clomiphene Wash-out
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Clomiphene Citrate
Patients receiving clomiphene citrate Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months 16 patients were enrolled
Three Months of Clomiphene Wash-out
Lost to Follow-up
1

Baseline Characteristics

Clomiphene Citrate for Treatment of Acromegaly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Clomiphene Citrate
n=16 Participants
Patients receiving clomiphene citrate Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months Patients with active acromegaly, defined by high IGF-1 levels, on regular use of a stable dose of Octreotide-LAR and/or Cabergoline for at least 1 year; IGF-1 above the reference range during the last year of follow-up; and T levels within or below the third inferior tertile of normality.
Age, Customized
52.5 years
n=39 Participants
Sex: Female, Male
Female
0 Participants
n=39 Participants
Sex: Female, Male
Male
16 Participants
n=39 Participants

PRIMARY outcome

Timeframe: Day 90

The objective is to compare the change of IGF-1 value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).

Outcome measures

Outcome measures
Measure
Clomiphene Citrate
n=16 Participants
Patients receiving clomiphene citrate Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months 16 patients were enrolled. IGF-1 values were assessed at D0 (baseline) and D90 (mean values)
IGF-1 Levels
424 ng/mL
Standard Deviation 108

SECONDARY outcome

Timeframe: D90

Population: 10 acromegalic patients were assessed, the other 6 patients did not have testosterone levels assessed.

The objective is to compare the change of testosterone value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).

Outcome measures

Outcome measures
Measure
Clomiphene Citrate
n=10 Participants
Patients receiving clomiphene citrate Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months 16 patients were enrolled. IGF-1 values were assessed at D0 (baseline) and D90 (mean values)
Testosterone Levels
282 ng/dL
Standard Deviation 210

SECONDARY outcome

Timeframe: Day 90

The objective is to compare the change of PSA value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).

Outcome measures

Outcome measures
Measure
Clomiphene Citrate
n=16 Participants
Patients receiving clomiphene citrate Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months 16 patients were enrolled. IGF-1 values were assessed at D0 (baseline) and D90 (mean values)
PSA Levels
2.0 ng/mL
Standard Deviation 2.0

Adverse Events

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. Felipe Henning Gaia Duarte

Hospital das Clinicas da Faculdade de Medicina da USP

Phone: +5511987550990

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place