MoodNCT01291056
Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation
A study testing Clomiphene in people with Mood, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mood
- What is being tested?
- Clomiphene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Menstruating women, ages 25-40, with regular menstrual cycles 23-35 days in length who elect to treat unexplained infertility using clomiphene citrate for superovulation combined with intrauterine insemination will be eligible for participation in this study.
- Eligible participants will be identified by physicians at the Utah Center for Reproductive Medicine at the University of Utah and will be provided written informed consent before being randomized to treatment groups.
- Male partner's semen analysis must show a sperm density of at least 10 million per ml, and motility of 20% or greater and normal morphology using World Health Organization (WHO) criteria.
Who cannot join
- Women with a history of depression or anxiety disorder requiring hospitalization or treatment lasting more than six months and women who currently or have received treatment during the previous six months for anxiety, depression or other psychiatric disorders listed in the 4th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) will be excluded.
- Women who have previously received treatment with clomiphene citrate will also be excluded from the study.
- Women using tobacco or illicit drugs will be excluded from study participation.
- Because the measurement tool used to measure symptoms has been validated only in women who can read and speak English, women who cannot speak and read English will not be eligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation: A Double-blind, Placebo-controlled, Crossover Study
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Mood
- Being tested
- Placebo, Clomiphene
- Keywords
- Clomiphene citrate, Mood symptoms, Infertility, Superovulation, Effects of clomiphene on mood
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle.
ClomipheneDrug
Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle.
| Study group | Role | What they receive |
|---|---|---|
| Clomphine | Active comparator | Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle. Receives: Drug: Clomiphene |
| Placebo | Placebo comparator | Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MoodStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Pittman, University of Utah
- Investigators
- Jessica Pittman, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291056
- Sponsor's protocol ID
- 00038807
- Status last verified
- May 2016
- First submitted
- 9 Nov 2010
- Last updated
- 28 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation: A Double-blind, Placebo-controlled, Crossover Study
- ClinicalTrials.gov ID
- NCT01291056
- Acronym / sponsor ID
- 00038807
- Conditions
- Mood
- Keywords
- Clomiphene citrate, Mood symptoms, Infertility, Superovulation, Effects of clomiphene on mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Posted 28 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomphine | Active comparator | Drug: ClomipheneEach participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle. |
| Placebo | Placebo comparator | Other: PlaceboEach participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Menstruating women, ages 25-40, with regular menstrual cycles 23-35 days in length who elect to treat unexplained infertility using clomiphene citrate for superovulation combined with intrauterine insemination will be eligible for participation in this study.
- Eligible participants will be identified by physicians at the Utah Center for Reproductive Medicine at the University of Utah and will be provided written informed consent before being randomized to treatment groups.
- Male partner's semen analysis must show a sperm density of at least 10 million per ml, and motility of 20% or greater and normal morphology using World Health Organization (WHO) criteria.
Key exclusion criteria (4 listed)
- Women with a history of depression or anxiety disorder requiring hospitalization or treatment lasting more than six months and women who currently or have received treatment during the previous six months for anxiety, depression or other psychiatric disorders listed in the 4th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) will be excluded.
- Women who have previously received treatment with clomiphene citrate will also be excluded from the study.
- Women using tobacco or illicit drugs will be excluded from study participation.
- Because the measurement tool used to measure symptoms has been validated only in women who can read and speak English, women who cannot speak and read English will not be eligible to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboEach participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle. | Other | Placebo |
| ClomipheneEach participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle. | Drug | Clomphine |
Primary outcome
Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment
Time frame: 1 year
To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.
Follicular Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment
Time frame: 1 Year
To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.
Luteal Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment
Time frame: 1 year
To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.
Luteal Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment
Time frame: 1 year
To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Pittman, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clomiphene in people with Mood, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.