Premenstrual Dysphoric DisorderPhase 3PH80-PMDNCT01217775
Intranasal PH80 Spray for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder
A Phase 3 study testing PH80 in people with Premenstrual Dysphoric Disorder, run by Pherin Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the effectiveness and safety in double-blind, randomized, placebo-controlled clinical trials of self administered PH80 intranasal spray for the acute management of cycle related symptoms in women who regularly experience premenstrual dysphoric disorder (PMDD). Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Premenstrual Dysphoric Disorder
- What is being tested?
- PH80
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jul 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, age 18 to 43 years, with regular menstrual cycles between 22 - 35 days in length inclusive.
- Women of childbearing potential may participate if they are not pregnant or breast feeding, and if they agree to use one of the following methods of contraception throughout the study: abstinence, intrauterine device, condom and foam, diaphragm and spermicide, vasectomy and spermicide, tubal ligation and spermicide, oral contraceptives and barrier method. Women using oral contraceptives must have been on a stable dosing regimen for at least 6 months prior to study entry and must agree to continue on that same dosing regimen throughout all phases of the study.
- Patients who reported at least a 1-year history of regularly experiencing PMDD.
- Patients who are able to read and understand the Informed Consent document; are willing and able to comply with the protocol; and who had read, understood, and voluntarily signed the written Informed Consent prior to the performance of any study-specific procedures.
Who cannot join
- Patients who fail to meet the study criteria for PMDD
- Patients with active diabetes mellitus, neurological, cardiac, renal, hepatic, or pulmonary disease, or with any other significant medical or gynecological abnormality or condition, as determined by physical examinations and/or clinical laboratory tests.
- Patients diagnosed with Major Depressive Disorder or Bipolar Depression.
- Patients with an acute or chronic condition that at the judgment of the clinical Investigator could harm the patient and/or alter the outcome of the study. Additional clinical examinations and symptom assessment will be performed at this time to determine continuing eligibility for study participation.
- Patients who used any intranasal medication other than study drug within 14 days prior to study entry and/or during the Run-In and/or Treatment Phases of the study.
- Patients with other clinical conditions or diseases, or those who were taking concomitant medications, which in the clinical judgment of the Investigator could place the patient at undue risk, interfere with study participation, or confound the results of the study.
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- Patients with current or last 2 years history of substance abuse.
- Patients who had a positive urine drug screen for any of the following: amphetamines, barbiturates, cocaine metabolites, opiates, benzodiazepines, and/or cannabinoids.
- Patients who had been treated previously with PH80.
- Patients who had participated in another research study or received another investigational drug within 30 days prior to study entry or during the study.
- Patients who used any other exclusionary prescription and/or nonprescription medications as specified in the study protocol (described in this report) within 14 days prior to study entry and/or during the Run-In and/or Treatment Phases of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Ellen W. Freeman, Ph.D., 215-662-3329
Ellen W. Freeman, Ph.D.
About this study
Official title: A Phase 3 Study of the Use of PH80 for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder
The objective of this study is to evaluate the effectiveness and safety in double-blind, randomized, placebo-controlled clinical trials of self administered PH80 intranasal spray for the acute management of cycle related symptoms in women who regularly experience premenstrual dysphoric disorder (PMDD).
Read the detailed description
Premenstrual disorders are characterized by negative mood, behavioral, and physical symptoms that occur consistently for several days to two weeks before menses, that can disrupt normal functioning, and that subside during the postmenstrual phase of the cycle. Marked irritability, marked depressed mood, marked anxiety, overeating of specific food cravings, mood swings, lack of energy, and pain are among the most common symptoms of moderate to severe premenstrual disorders.
It is estimated that 75% women of reproductive age (menarche to perimenopause) experience physical and behavioral symptoms premenstrually and in 40% women symptoms are intense (moderate to severe) and require medical attention. For 3-8 % women premenstrual symptoms are severe enough to interfere with work and interpersonal relationships. Premenstrual Dysphoric Disorder (PMDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) research criteria, represents the more severe and disabling end of the premenstrual disorders spectrum. For women with severe premenstrual symptoms or PMDD, these symptoms are bothersome enough to produce an impact on psychological and/or occupational functioning, and professional attention is required.
Selective serotonin reuptake inhibitors (SSRIs) fluoxetine, sertaline and paroxetine have been approved by the United States Food and Drug Administration (FDA) as a chronic treatment for PMDD, however the use of SSRIs significantly increases the risk of suicide in adolescents and young adults. Antidepressants are also associated with significant relapse during short and long term treatment of PMDD. Contraceptives are also prescribed to treat moderate and severe premenstrual symptoms, but besides the severe adverse effects (drospirenone and ethinyl estradiol) they re not the treatment choice for women willing to become pregnant.
Pherin Pharmaceuticals synthesized a number of pherines and screened them for biologic activity in vitro. PH80 is a pherine shown to bind to a subset of peripheral receptors in nasal chemosensory neurons. Pherines such as PH80 are thought to exert their activity by rapid stimulation of the hypothalamus, which does not require systemic uptake and distribution. PH80 is being investigated as a potential treatment in women that suffer the cycle related symptoms of Premenstrual Dysphoric Disorder.
Each single administration of PH80 to be tested in this study will deliver a similar amount of PH80 (800 nanogram) to the nasal passages as was found in previous investigations (Pherin Clinical Study #PH80 CL003, #PH80 CL015 and #PH80 CL016) to improve premenstrual symptoms in PMDD patients when administered intranasally on an acute basis.
- Conditions
- Premenstrual Dysphoric Disorder
- Being tested
- PH80, Placebo intranasal spray
- Keywords
- PMDD, Premenstrual, Dysphoria, Mood Swings, Bloating.
- Medical subject headings
- Premenstrual Dysphoric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH80Drug
PH80 intranasal spray 800 nanograms
Placebo intranasal sprayDrug
Placebo intranasal spray
| Study group | Role | What they receive |
|---|---|---|
| PH80 intranasal spray | Experimental | Start using study medication on 14th of the cycle, or the day symptoms start to bother, or if no symptoms on day 21st of the cycle but no later than day 21st of the cycle, up to 6-times per day, and continuing until day 2-3 of the menses Receives: Drug: PH80 |
| Placebo intranasal spray | Placebo comparator | Start using study medication on 14th of the cycle, or the day symptoms start to bother, or if no symptoms on day 21st of the cycle but no later than day 21st of the cycle, up to 6-times per day, and continuing until day 2-3 of the menses Receives: Drug: Placebo intranasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Record of Severity of Problems (DRSP)scores
Primary outcome meassure: difference between average luteal phase DRSP total scores from 2 qualification cycles and average luteal phase DRSP socores from 6 treatment cycles.
Measured: Daily DRSP sores
Secondary outcomes (1)
Patient Global Evaluation (PGE)
Secondary outcome measures include: each of the 11 individual items of the DRSP, scheduled patient and Investigator global evaluations of the patients' PMDD symptoms, including patient-rated Global Evaluations (PGE) and Investigator rated Clinical Global Impression (CGI) ratings.
Measured: Daily PGE scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premenstrual Dysphoric DisorderStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pherin Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ellen W Freeman, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217775
- Sponsor's protocol ID
- PH80 CL019
- Acronym
- PH80-PMD
- Status last verified
- Dec 2015
- First submitted
- 7 Oct 2010
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Freeman, Ellen W. and Monti, Louis. Evaluation of a unique low dose intranasal aerosol for the treatment of clinically significant premenstrual symptomes NCDEU (New Clinical Drug Evaluation Unit)47th Annual Meeting,June 2007.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study of the Use of PH80 for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder
- ClinicalTrials.gov ID
- NCT01217775
- Acronym / sponsor ID
- PH80-PMD / PH80 CL019
- Conditions
- Premenstrual Dysphoric Disorder
- Keywords
- PMDD, Premenstrual, Dysphoria, Mood Swings, Bloating.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Pherin Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effectiveness and safety in double-blind, randomized, placebo-controlled clinical trials of self administered PH80 intranasal spray for the acute management of cycle related symptoms in women who regularly experience premenstrual dysphoric disorder (PMDD).
Detailed description
Premenstrual disorders are characterized by negative mood, behavioral, and physical symptoms that occur consistently for several days to two weeks before menses, that can disrupt normal functioning, and that subside during the postmenstrual phase of the cycle. Marked irritability, marked depressed mood, marked anxiety, overeating of specific food cravings, mood swings, lack of energy, and pain are among the most common symptoms of moderate to severe premenstrual disorders.
It is estimated that 75% women of reproductive age (menarche to perimenopause) experience physical and behavioral symptoms premenstrually and in 40% women symptoms are intense (moderate to severe) and require medical attention. For 3-8 % women premenstrual symptoms are severe enough to interfere with work and interpersonal relationships. Premenstrual Dysphoric Disorder (PMDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) research criteria, represents the more severe and disabling end of the premenstrual disorders spectrum. For women with severe premenstrual symptoms or PMDD, these symptoms are bothersome enough to produce an impact on psychological and/or occupational functioning, and professional attention is required.
Selective serotonin reuptake inhibitors (SSRIs) fluoxetine, sertaline and paroxetine have been approved by the United States Food and Drug Administration (FDA) as a chronic treatment for PMDD, however the use of SSRIs significantly increases the risk of suicide in adolescents and young adults. Antidepressants are also associated with significant relapse during short and long term treatment of PMDD. Contraceptives are also prescribed to treat moderate and severe premenstrual symptoms, but besides the severe adverse effects (drospirenone and ethinyl estradiol) they re not the treatment choice for women willing to become pregnant.
Pherin Pharmaceuticals synthesized a number of pherines and screened them for biologic activity in vitro. PH80 is a pherine shown to bind to a subset of peripheral receptors in nasal chemosensory neurons. Pherines such as PH80 are thought to exert their activity by rapid stimulation of the hypothalamus, which does not require systemic uptake and distribution. PH80 is being investigated as a potential treatment in women that suffer the cycle related symptoms of Premenstrual Dysphoric Disorder.
Each single administration of PH80 to be tested in this study will deliver a similar amount of PH80 (800 nanogram) to the nasal passages as was found in previous investigations (Pherin Clinical Study #PH80 CL003, #PH80 CL015 and #PH80 CL016) to improve premenstrual symptoms in PMDD patients when administered intranasally on an acute basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PH80 intranasal spray | Experimental | Drug: PH80Start using study medication on 14th of the cycle, or the day symptoms start to bother, or if no symptoms on day 21st of the cycle but no later than day 21st of the cycle, up to 6-times per day, and continuing until day 2-3 of the menses |
| Placebo intranasal spray | Placebo comparator | Drug: Placebo intranasal sprayStart using study medication on 14th of the cycle, or the day symptoms start to bother, or if no symptoms on day 21st of the cycle but no later than day 21st of the cycle, up to 6-times per day, and continuing until day 2-3 of the menses |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female, age 18 to 43 years, with regular menstrual cycles between 22 - 35 days in length inclusive.
- Women of childbearing potential may participate if they are not pregnant or breast feeding, and if they agree to use one of the following methods of contraception throughout the study: abstinence, intrauterine device, condom and foam, diaphragm and spermicide, vasectomy and spermicide, tubal ligation and spermicide, oral contraceptives and barrier method. Women using oral contraceptives must have been on a stable dosing regimen for at least 6 months prior to study entry and must agree to continue on that same dosing regimen throughout all phases of the study.
- Patients who reported at least a 1-year history of regularly experiencing PMDD.
- Patients who are able to read and understand the Informed Consent document; are willing and able to comply with the protocol; and who had read, understood, and voluntarily signed the written Informed Consent prior to the performance of any study-specific procedures.
Key exclusion criteria (11 listed)
- Patients who fail to meet the study criteria for PMDD
- Patients with active diabetes mellitus, neurological, cardiac, renal, hepatic, or pulmonary disease, or with any other significant medical or gynecological abnormality or condition, as determined by physical examinations and/or clinical laboratory tests.
- Patients diagnosed with Major Depressive Disorder or Bipolar Depression.
- Patients with an acute or chronic condition that at the judgment of the clinical Investigator could harm the patient and/or alter the outcome of the study. Additional clinical examinations and symptom assessment will be performed at this time to determine continuing eligibility for study participation.
- Patients who used any intranasal medication other than study drug within 14 days prior to study entry and/or during the Run-In and/or Treatment Phases of 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 |
|---|---|---|
| PH80PH80 intranasal spray 800 nanograms | Drug | PH80 intranasal spray |
| Placebo intranasal sprayPlacebo intranasal spray | Drug | Placebo intranasal spray |
Primary outcome
Daily Record of Severity of Problems (DRSP)scores
Time frame: Daily DRSP sores
Primary outcome meassure: difference between average luteal phase DRSP total scores from 2 qualification cycles and average luteal phase DRSP socores from 6 treatment cycles.
1 secondary outcome
Patient Global Evaluation (PGE)
Time frame: Daily PGE scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- BackgroundFreeman, Ellen W. and Monti, Louis. Evaluation of a unique low dose intranasal aerosol for the treatment of clinically significant premenstrual symptomes NCDEU (New Clinical Drug Evaluation Unit)47th Annual Meeting,June 2007.
- educational webpage about premenstrual symptoms and PMDDLink provided by the sponsor.
Related trials for Premenstrual Dysphoric Disorder
Not yet recruitingPhase 1
MLS101 Study in PMDD
Premenstrual Dysphoric Disorder ( PMDD), PMDD
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
RecruitingObservational study
Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
Premenstrual Dysphoric Disorder (PMDD)
Not yet recruitingObservational study
The SPARK-PMDD Study
Premenstrual Dysphoric Disorder, PMDD
RecruitingObservational study
To Establish Whether Individuals With Premenstrual Dysphoric Disorder (PMDD) Demonstrate a Different Luteal-phase Sex Hormone Profile and Ratio Compared With Asymptomatic Controls.
Premenstrual Dysphoric Disorder ( PMDD)
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.
Ellen W Freeman, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PH80 in people with Premenstrual Dysphoric Disorder, run by Pherin Pharmaceuticals, Inc. 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 3 Dec 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellen W. Freeman, Ph.D. (215-662-3329, fremane@mail.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Record of Severity of Problems (DRSP)scores (time frame: Daily DRSP sores). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01217775, which also lists 1 linked publication.
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 3 Dec 2015.