An interventional study of Placebo and Clomiphene in Mood, sponsored by University of Utah. Completed at 1 site in United States. Open to female participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-28.
Sponsored by University of Utah · Not applicable and Interventional
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.
The aim of this study is to identify psychological and physical symptoms experienced by women taking clomiphene citrate for superovulation in a prospective setting.
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 infertility1. While clomiphene citrate is generally well tolerated, common side effects have been reported including vasomotor flushes, breast tenderness, pelvic discomfort, and mood swings. Visual changes, such as palenopsia are rarely reported2. The side effect profile reported by some women using clomiphene citrate is similar to symptoms of premenstrual dysphoric disorder (PMDD). Symptoms of PMDD include tension, irritability, depressed mood, affective lability, lack of energy, difficulty concentrating, and physical symptoms such as breast tenderness, bloating, headache joint and muscle pain. Several validated scales have been used to record symptom occurrences and to characterize the timing of symptom occurrence relative to the menstrual cycle3.
The psychological and mood side effects of clomiphene citrate in women undergoing infertility treatment have been studied to a limited degree. One study reported mood swings in 9 out of 14 women surveyed4. Another small study found a higher frequency of irritability, mood swings, feeling down and bloating in women undergoing fertility treatment who were taking clomiphene citrate compared to no medication.
2,540 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's enrollment of 20 is below the median of 120 across 1,722 interventional studies indexed under Infertility.
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Of its 111 completed or terminated interventional studies of FDA-regulated products, 64 (58%) have results posted.
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Exclusion Criteria:
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.
Other: Placebo
Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle.
Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle.
Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment
To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.
Time frame: 1 year
Follicular Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment
To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.
Time frame: 1 Year
Luteal Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment
To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.
Time frame: 1 year
Luteal Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment
To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.
Time frame: 1 year
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.
| Milestone | Clomiphene Citrate, Then Placebo | Placebo, Then Clomiphene Citrate |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| Milestone | Clomiphene Citrate, Then Placebo | Placebo, Then Clomiphene Citrate |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| Milestone | Clomiphene Citrate, Then Placebo | Placebo, Then Clomiphene Citrate |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.
| units on a scale | Clomiphene Citrate | Placebo |
|---|---|---|
| Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment | 3 (0 to 6) | 5 (1 to 18) |
To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.
| units on a scale | Clomiphene Citrate | Placebo |
|---|---|---|
| Follicular Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment | 10 (2.25 to 14) | 8 (5 to 26) |
To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.
| units on a scale | Clomiphene Citrate | Placebo |
|---|---|---|
| Luteal Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment | 5 (0 to 14.5) | 2 (0 to 13) |
To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.
| units on a scale | Clomiphene Citrate | Placebo |
|---|---|---|
| Luteal Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment | 9 (3.25 to 15) | 9 (0 to 28) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clomiphene Citrate, Then Placebo | — | 0/10 (0%) | 0/10 (0%) |
| Placebo, Then Clomiphene Citrate | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Clomiphene Citrate, Then Placebo | Placebo, Then Clomiphene Citrate | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Clomiphene Citrate, Then Placebo | Placebo, Then Clomiphene Citrate | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 0 | 0 | 0 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jan 2010, a primary completion of May 2011 and a completion of May 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2016, 5 years 1 month after primary completion.
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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clomiphene