Premenstrual Dysphoric DisorderPhase 2NCT03697265
A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)
A Phase 2 study testing Sepranolone (UC1010) low dose and Sepranolone (UC1010) high dose in people with Premenstrual Dysphoric Disorder, run by Asarina Pharma at 12 sites in 4 countries.
Trial summary
The objective of this phase IIb study is to evaluate the effect and safety of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD). Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two weeks preceding the menstruation of three… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Premenstrual Dysphoric Disorder
- What is being tested?
- Sepranolone (UC1010) low dose and Sepranolone (UC1010) high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 475 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 20 Apr 2018to 23 Oct 2020
- Phase
- Phase 2
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Main Inclusion Criteria:
- have PMDD according to DSM-5 verified in two menstrual cycles
- have a regular menstrual cycle of 24-35 days cycle,
- use double barrier contraception, non-hormonal IUD, be truly sexually abstinent, or subject or her partner has been surgically sterilized,
Main Exclusion Criteria:
- steroid hormonal treatment or treatment with psychopharmaceuticals during previous three months
- treatments for premenstrual syndrome (PMS) or PMDD
- history of or significant medical condition ongoing
- be pregnant or plan a pregnancy within the study period
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Germany5 sites
Zentrum für Klinische Forschnung
Bad Homburg
Emovis
Berlin
Medizentrum Essen Borbeck
Essen
Klinische Forschung Karlsruhe GmbH
Karlsruhe
Praxis Dr. Steinwachs
Nuremberg
Poland3 sites
Centrum Kliniczno-Badawcze
Elblag
Centrum Medyczne Angelius Provita
Katowice
ProCreative
Krakow
United Kingdom3 sites
Liverpool Women's NHS Foundation Trust
Liverpool
Imperial College London
London
Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire
Stoke-on-Trent, ST4 6QG
About this study
Official title: A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre Study Investigating Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)
The objective of this phase IIb study is to evaluate the effect and safety of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD). Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two weeks preceding the menstruation of three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms. Sepranolone is an endogenous steroid.
Read the detailed description
The objective of this phase IIb study is to evaluate the effect and safety of two doses of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) in comparison to placebo, administrated during the luteal phase of three consecutive menstrual cycles. Effect will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms and impairment of symptoms on daily life of the patients. The scale is Daily Record of Severity of Problems (DRSP). Preceding the treatment period, the diagnosis of PMDD will be established in the study participants by at lest two menstrual cycles of prospective DRSP ratings by the patients. This period will also constitute the baseline data. The effect of study medication will be assessed as the change in symptoms from baseline to during treatment. The Total symptom score of the DRSP will constitute the primary variable and the late luteal phase ratings in the respective menstrual cycles, before and during treatment, will be used.
The study will also include a follow-up (no treatment) cycle before patients final visit.
The study is conducted in four European countries (Sweden, Germany, Poland and United Kingdom) and will include up to 225 patients.
- Conditions
- Premenstrual Dysphoric Disorder
- Being tested
- Sepranolone (UC1010) low dose, Sepranolone (UC1010) high dose, Placebo
- 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.
Sepranolone (UC1010) low doseDrug
Subcutaneous (SC) administration
Sepranolone (UC1010) high doseDrug
Subcutaneous (SC) administration
PlaceboDrug
Subcutaneous (SC) adminstration
| Study group | Role | What they receive |
|---|---|---|
| Sepranolone (UC1010) low dose | Experimental | Sepranolone (UC1010) low dose administered subcutaneously (SC) during the luteal phase Receives: Drug: Sepranolone (UC1010) low dose |
| Sepranolone (UC1010) high dose | Experimental | Sepranolone (UC1010) high dose administered subcutaneously (SC) during the luteal phase Receives: Drug: Sepranolone (UC1010) high dose |
| Placebo | Placebo comparator | Placebo administered subcutaneously (SC) during the luteal phase Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on DRSP Total symptom score
Change in DRSP Total symptom score (Daily Record of Severity of Problems) measured during the luteal phase (i.e. the week before menstruation) before and during treatment
Measured: Baseline luteal phase score (average from two menstrual cycles) vs. luteal phase score during treatment.
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Recording of adverse events
Measured: Starting from first dose given until 1 months after treatment stop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start20 Apr 2018
- Primary completion28 Jul 2020
- Study completion23 Oct 2020
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asarina Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ergomed
- Responsible party
- Sponsor
- Investigators
- Shaughn O'Brien, MD, Principal investigator, Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697265
- Sponsor's protocol ID
- UM203
- Status last verified
- Oct 2020
- First submitted
- 28 Sep 2018
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bixo M, Ekberg K, Poromaa IS, Hirschberg AL, Jonasson AF, Andreen L, Timby E, Wulff M, Ehrenborg A, Backstrom T. Treatment of premenstrual dysphoric disorder with the GABAA receptor modulating steroid antagonist Sepranolone (UC1010)-A randomized controlled trial. Psychoneuroendocrinology. 2017 Jun;80:46-55. doi: 10.1016/j.psyneuen.2017.02.031. Epub 2017 Mar 1.
PubMed 28319848
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre Study Investigating Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)
- ClinicalTrials.gov ID
- NCT03697265
- Acronym / sponsor ID
- UM203
- Conditions
- Premenstrual Dysphoric Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Asarina PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Ergomed
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 5 Oct 2018 (actual)
- 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 phase IIb study is to evaluate the effect and safety of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD). Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two weeks preceding the menstruation of three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms. Sepranolone is an endogenous steroid.
Detailed description
The objective of this phase IIb study is to evaluate the effect and safety of two doses of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) in comparison to placebo, administrated during the luteal phase of three consecutive menstrual cycles. Effect will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms and impairment of symptoms on daily life of the patients. The scale is Daily Record of Severity of Problems (DRSP). Preceding the treatment period, the diagnosis of PMDD will be established in the study participants by at lest two menstrual cycles of prospective DRSP ratings by the patients. This period will also constitute the baseline data. The effect of study medication will be assessed as the change in symptoms from baseline to during treatment. The Total symptom score of the DRSP will constitute the primary variable and the late luteal phase ratings in the respective menstrual cycles, before and during treatment, will be used.
The study will also include a follow-up (no treatment) cycle before patients final visit.
The study is conducted in four European countries (Sweden, Germany, Poland and United Kingdom) and will include up to 225 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sepranolone (UC1010) low dose | Experimental | Drug: Sepranolone (UC1010) low doseSepranolone (UC1010) low dose administered subcutaneously (SC) during the luteal phase |
| Sepranolone (UC1010) high dose | Experimental | Drug: Sepranolone (UC1010) high doseSepranolone (UC1010) high dose administered subcutaneously (SC) during the luteal phase |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered subcutaneously (SC) during the luteal phase |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Sepranolone (UC1010) low doseSubcutaneous (SC) administration | Drug | Sepranolone (UC1010) low dose |
| Sepranolone (UC1010) high doseSubcutaneous (SC) administration | Drug | Sepranolone (UC1010) high dose |
| PlaceboSubcutaneous (SC) adminstration | Drug | Placebo |
Primary outcome
Effect on DRSP Total symptom score
Time frame: Baseline luteal phase score (average from two menstrual cycles) vs. luteal phase score during treatment.
Change in DRSP Total symptom score (Daily Record of Severity of Problems) measured during the luteal phase (i.e. the week before menstruation) before and during treatment
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Starting from first dose given until 1 months after treatment stop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Background: PubMed 28319848Bixo M, Ekberg K, Poromaa IS, Hirschberg AL, Jonasson AF, Andreen L, Timby E, Wulff M, Ehrenborg A, Backstrom T. Treatment of premenstrual dysphoric disorder with the GABAA receptor modulating steroid antagonist Sepranolone (UC1010)-A randomized controlled trial. Psychoneuroendocrinology. 2017 Jun;80:46-55. doi: 10.1016/j.psyneuen.2017.02.031. Epub 2017 Mar 1.
- Individual participant dataSharing planned: No
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.
Shaughn O'Brien, MD principal investigator
Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sepranolone (UC1010) low dose and Sepranolone (UC1010) high dose in people with Premenstrual Dysphoric Disorder, run by Asarina Pharma at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Poland, United Kingdom, Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect on DRSP Total symptom score (time frame: Baseline luteal phase score (average from two menstrual cycles) vs. luteal phase score during treatment.). 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 NCT03697265, 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 28 Oct 2020.