HealthyPhase 4NCT00611975
Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning
A Phase 4 study testing Fluoxetine and Bupropion in people with Healthy, run by Weill Medical College of Cornell University.
Trial summary
This study will evaluate the effect of antidepressants on sex hormone levels in women and if the potential changes in sex hormone levels are related to sexual side effects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fluoxetine and Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Sep 2008
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regular menstrual cycles that are 25 to 35 days in length during the 1 year prior to study entry
- Willing to engage in sexual activity, alone or with a partner, at least weekly for the duration of the study
- Willing to use effective birth control (e.g., condom, diaphragm with spermicide, tubal ligation, nonhormonal intrauterine device,, partner with vasectomy) for the duration of the study
Who cannot join
- Medical illness that may contribute to sexual dysfunction or affect steroid hormone levels
- Body mass index (BMI) greater than 30
- Elevated testosterone at screening
- History of seizure disorder
- Consumes more than 10 alcoholic beverages per week
About this study
Official title: Effect of Serotonin Reuptake Inhibitors on Gonadal Steroid Hormones
This study will evaluate the effect of antidepressants on sex hormone levels in women and if the potential changes in sex hormone levels are related to sexual side effects.
Read the detailed description
Depression is a leading cause of disability in women, with women being two times more likely than men to develop depression. Depression affects a person's body, thoughts, mood, and behavior, often making normal day-to-day functioning difficult. Fortunately, depression is a condition that is highly treatable with one or more of the antidepressant medications and forms of psychotherapy available. Serotonin reuptake inhibitors (SRIs) are a recent class of antidepressants that have been successful in alleviating symptoms of depression. Although the side effects of SRIs are less than those of other types of antidepressants, a number of people taking SRIs experience sexual dysfunction, including reduced desire and difficulty with orgasm. It is believed that SRI treatment may interfere with gonadal production of steroid hormones, thus leading to changes in sexual function. This study will compare the effects of the SRI fluoxetine with the effects of the non-SRI bupropion on circulating levels of sex hormones in healthy women and on any related sexual side effects.
Participation in this study will last 3 months. Potential participants will undergo initial screening, which will involve a blood draw, drug and pregnancy tests, physical exam, electrocardiogram, and psychiatric diagnostic interview. Participants will also complete an interview and questionnaire about sexual functioning. All eligible participants will then be asked to return for a total of 9 study visits over 3 months.
Participants will undergo 1 month of baseline hormonal sampling and 2 months of daily treatment with either fluoxetine or bupropion. The study visits will be scheduled around three points in the menstrual cycle (early follicular, ovulatory, and luteal), with each visit including a blood draw and repeat questionnaire on sexual functioning. Participants will be asked to perform daily urine tests, beginning 10 days after the start of menstruation and continuing for up to 8 days until detection of the luteinizing hormone surge, which signals ovulation. Participants will be asked to keep a diary of luteinizing hormone surges, dates of menstruation, and sexual activities. At the Month 3 visit, participants will discontinue their assigned medication and will complete their final blood draw and questionnaire.
- Conditions
- Healthy
- Being tested
- Fluoxetine, Bupropion
- Keywords
- Gonadal Steroid Hormones, Healthy Volunteers, Antidepressant Side Effects, Fluoxetine, Bupropion, Prolactin, Testosterone, Estradiol, Progesterone, Sexual Function, Serotonin Reuptake Inhibitors, 17-OH Pregnenolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called Prozac, Sarafem
Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine.
BupropionDrug
Also called Wellbutrin, Zyban
Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Participants will receive treatment with fluoxetine for 2 months Receives: Drug: Fluoxetine |
| B | Experimental | Participants will receive treatment with bupropion for 2 months Receives: Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 17-OH Pregnenolone
Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Effects of the two antidepressant treatments and menstrual cycle on hormone level were examined.
Measured: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Secondary outcomes (10)
Change in Arizona Sexual Experiences Scale (ASEX)
A five-item scale with each item scored from 1 to 6. Score range is 5 to 30. Higher scores indicate more sexual dysfunction.
Scores at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on ASEX scores were examined.
Measured: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Change in Free Testosterone
Free testosterone was calculated from total testosterone ng/ml divided by sex hormone binding globulin (SHBG) nmol/l multiplied by 100. Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined.
Measured: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Change in Estradiol
Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined.
Measured: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Change in Prolactin
Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined.
Measured: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Change in Progesterone
Hormone levels at early follicular, ovulation, and luteal phase of the cycle were averaged for the baseline pre-treatment month and compared to average values during the 1st and 2nd months of antidepressant treatment.
Measured: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Change in Dehydroepiandrosterone Sulfate (DHEA-S)
Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined.
Measured: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Change in Androstenedione
Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined.
Measured: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
C-reactive Protein
Measured: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Inflammatory Cytokines
Measured: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Lymphocyte Activation Markers
Measured: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startOct 2005
- Primary completionMay 2008
- Study completionSep 2008
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 HealthyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Margaret Altemus, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611975
- Sponsor's protocol ID
- R21MH071543
- Other IDs
- R21MH071543, DNBBS 73-MCR
- Status last verified
- Nov 2020
- First submitted
- 6 Feb 2008
- Last updated
- 10 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Serotonin Reuptake Inhibitors on Gonadal Steroid Hormones
- ClinicalTrials.gov ID
- NCT00611975
- Acronym / sponsor ID
- R21MH071543
- Conditions
- Healthy
- Keywords
- Gonadal Steroid Hormones, Healthy Volunteers, Antidepressant Side Effects, Fluoxetine, Bupropion, Prolactin, Testosterone, Estradiol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of antidepressants on sex hormone levels in women and if the potential changes in sex hormone levels are related to sexual side effects.
Detailed description
Depression is a leading cause of disability in women, with women being two times more likely than men to develop depression. Depression affects a person's body, thoughts, mood, and behavior, often making normal day-to-day functioning difficult. Fortunately, depression is a condition that is highly treatable with one or more of the antidepressant medications and forms of psychotherapy available. Serotonin reuptake inhibitors (SRIs) are a recent class of antidepressants that have been successful in alleviating symptoms of depression. Although the side effects of SRIs are less than those of other types of antidepressants, a number of people taking SRIs experience sexual dysfunction, including reduced desire and difficulty with orgasm. It is believed that SRI treatment may interfere with gonadal production of steroid hormones, thus leading to changes in sexual function. This study will compare the effects of the SRI fluoxetine with the effects of the non-SRI bupropion on circulating levels of sex hormones in healthy women and on any related sexual side effects.
Participation in this study will last 3 months. Potential participants will undergo initial screening, which will involve a blood draw, drug and pregnancy tests, physical exam, electrocardiogram, and psychiatric diagnostic interview. Participants will also complete an interview and questionnaire about sexual functioning. All eligible participants will then be asked to return for a total of 9 study visits over 3 months.
Participants will undergo 1 month of baseline hormonal sampling and 2 months of daily treatment with either fluoxetine or bupropion. The study visits will be scheduled around three points in the menstrual cycle (early follicular, ovulatory, and luteal), with each visit including a blood draw and repeat questionnaire on sexual functioning. Participants will be asked to perform daily urine tests, beginning 10 days after the start of menstruation and continuing for up to 8 days until detection of the luteinizing hormone surge, which signals ovulation. Participants will be asked to keep a diary of luteinizing hormone surges, dates of menstruation, and sexual activities. At the Month 3 visit, participants will discontinue their assigned medication and will complete their final blood draw and questionnaire.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: FluoxetineParticipants will receive treatment with fluoxetine for 2 months |
| B | Experimental | Drug: BupropionParticipants will receive treatment with bupropion for 2 months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Regular menstrual cycles that are 25 to 35 days in length during the 1 year prior to study entry
- Willing to engage in sexual activity, alone or with a partner, at least weekly for the duration of the study
- Willing to use effective birth control (e.g., condom, diaphragm with spermicide, tubal ligation, nonhormonal intrauterine device,, partner with vasectomy) for the duration of the study
Key exclusion criteria (5 listed)
- Medical illness that may contribute to sexual dysfunction or affect steroid hormone levels
- Body mass index (BMI) greater than 30
- Elevated testosterone at screening
- History of seizure disorder
- Consumes more than 10 alcoholic beverages per week
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 |
|---|---|---|
| FluoxetineAlso: Prozac, SarafemParticipants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine. | Drug | A |
| BupropionAlso: Wellbutrin, ZybanParticipants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion. | Drug | B |
Primary outcome
Change in 17-OH Pregnenolone
Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Effects of the two antidepressant treatments and menstrual cycle on hormone level were examined.
10 secondary outcomes
Change in Arizona Sexual Experiences Scale (ASEX)
Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Change in Free Testosterone
Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Change in Estradiol
Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Change in Prolactin
Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Change in Progesterone
Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Change in Dehydroepiandrosterone Sulfate (DHEA-S)
Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Change in Androstenedione
Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
C-reactive Protein
Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Inflammatory Cytokines
Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Lymphocyte Activation Markers
Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Margaret Altemus, MD principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoxetine and Bupropion in people with Healthy, run by Weill Medical College of Cornell University.
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 5 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2020). 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?
Change in 17-OH Pregnenolone (time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles). 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 10 Dec 2020.