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Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation

NCT01291056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-06-28

Study results available
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Summary

Clomiphene citrate is commonly used for ovulation induction in women with anovulation, correction of luteal phase deficiency or for superovulation as empiric therapy for unexplained infertility. Superovulation using clomiphene, usually with intrauterine insemination, is usually regarded as first line therapy for unexplained infertility, infertility due to mild endometriosis, or infertility with mild or moderate compromise of the male factor. The side effect profile reported by some women using clomiphene citrate is similar to symptoms of premenstrual dysphoric disorder (PMDD), including tension, irritability, depressed mood, affective lability, lack of energy, difficulty concentrating, and physical symptoms such as breast tenderness, bloating, headache joint and muscle pain. Few studies have been performed to examine the relationship between clomiphene citrate and mood symptoms; however, these studies have been limited by their small sample size, potential for recall bias and lack of randomization. Moreover, the experience of infertility is dysphoric in and of itself. Therefore, a rigorous evaluation of whether, when in the cycle, and how often clomiphene is associated with mood changes is needed. Such a study would add to the body of literature on this topic in three important ways: 1) use of prospective data collection to more accurately identify commonly reported symptoms, 2) characterize the timing of symptom occurrence relative to treatment cycle, and 3) provide information relevant to planning of future studies involving targeted treatment of clomiphene citrate induced symptoms. If clomiphene use is shown to affect mood, the results would point to an important avenue for psychopharmacologic insight into relationships between mood and sex steroids.

OBJECTIVES:

Specific Aim #1: To identify psychological and physical symptoms experienced by women taking clomiphene citrate for superovulation in a prospective, placebo controlled trial setting.

Specific Aim #2: To determine whether measures of the emotional and physical state prior to the administration of clomiphene, predict the occurrence of mood changes during the five days of clomiphene administration and in the late follicular and luteal phases of the cycle in which clomiphene was administered.

Conditions

  • Mood

Interventions

OTHER

Placebo

Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle.

DRUG

Clomiphene

Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle.

Sponsors & Collaborators

Principal Investigators

  • Jessica Pittman, M.D. · University of Utah

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01291056 on ClinicalTrials.gov