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NCT01291056 · ClinicalTrials.gov registry record · NA
Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation
A NA study of Mood, sponsored by University of Utah.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01291056 is a NA study of Mood that has completed, run by University of Utah. The registered enrollment target is 20 participants, below the 3,659-participant average among 29 other Mood trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01291056, a NA study of Mood, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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: T
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Clomiphene
Study Locations (1)
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01291056
The ClinicalTrials.gov registry entry for NCT01291056 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,659-participant average among 29 other Mood trials with a reported enrollment target (99% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Mood appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01291056 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT01291056 about?
NCT01291056 is a clinical study titled "Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation". 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 lin...
What is the current status of trial NCT01291056?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2010-01. Estimated completion is 2011-05.
What conditions does trial NCT01291056 study?
This clinical trial studies the following conditions: Mood.
What interventions are being tested in trial NCT01291056?
The interventions under investigation include: Placebo (OTHER), Clomiphene (DRUG).
Who is sponsoring clinical trial NCT01291056?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01291056 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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