Premenstrual SyndromeOLPPMS_1NCT03547661
Open-Label Placebo Treatment of Women With Premenstrual Syndrome
A study testing P-Dragees rosa Lichtenstein in people with Premenstrual Syndrome, run by Jens Gaab at 1 site in Switzerland.
Trial summary
This study aims to investigate the effect of an open-label placebo intervention on premenstrual syndrome (PMS) complaints. Women who suffer from moderate to severe PMS will be randomly allocated to three groups: to a treatment as usual group, an open-label placebo group, and an integrative open-label placebo group. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- P-Dragees rosa Lichtenstein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Aug 2018to 28 Jun 2021
- Phase
- Interventional
- 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
Who may be able to join
- Moderate to severe PMS
- Between 18 and 45 years of age
- A regular menstrual cycle, i.e., max. +/- 3 days of difference of cycle range
- Menstrual cycle range not longer than 31 or shorter than 24 days
- Participants have a general practioner or gynaecologist to consult
- At least one premenstrual symptom causes the desire for a PMS treatment
Who cannot join
- Brest feeding at the moment or during the last three months
- Pregnancy
- Failing menstruation onset in the course of two consecutive menstrual cycles
- An essential mental or somatic disease
- Drug or massive alcohol intake or of other psychoactive substances
- Uptake of a new medication within the last 30 days
Show all 12Show fewer
- Menopause, premenopausal strain or amenorrhoea
- Allergy of one of the ingredients of the placebo dragées (P-Dragees rosa Lichtenstein)
- Women who are surgically sterilised, hysterectomised, or ovariectomised
- BMI above 30
- Actual or recent participation in psychotherapy due to premenstrual symptoms
- Parallel participation in another study with investigational drugs or participation in another PMS study within the last three months
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy
Basel, Canton of Basel-City, 4055
About this study
Official title: Open-Label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial
This study aims to investigate the effect of an open-label placebo intervention on premenstrual syndrome (PMS) complaints. Women who suffer from moderate to severe PMS will be randomly allocated to three groups: to a treatment as usual group, an open-label placebo group, and an integrative open-label placebo group. Participants of all groups will conclude a prospective PMS screening for one menstrual cycle. Thereafter, participants of both intervention groups will obtain an openly administered placebo intervention for six weeks. Participants of the treatment as usual group will have the chance to obtain the same open-label placebo intervention after study conduct. Diverse measures will be assessed by means of a PMS symptom diary and questionnaires. Furthermore, we assess participants experiences of study participation qualitatively by means of semi-structured interviews.
Read the detailed description
Recent evidence suggests that in certain clinical conditions - such as chronic low-back pain, migraine, irritable bowel syndrome, attention deficit hyperactivity disorder, and rhinitis - placebos improve clinical outcomes even without deception. Premenstrual syndrome (PMS) is defined as clinically significant symptoms, comprising at least one emotional or physical symptom in the premenstrual phase of the menstrual cycle and which cause substantial distress or functional impairment. To date, there exists no study examining open-label placebo responses on PMS. However, PMS seems to be considerably susceptible to placebo effects: The Royal College of Obstetricians and Gynaecologists alerts to substantial placebo responses in randomized-controlled PMS trials and studies showed considerable placebo effects on PMS without any specific effect for the medication under examination. Furthermore, a myriad of distinctive therapies is described for PMS (including pharmacological and phytopharmaceutical drugs as well as complementary non-pharmacological interventions), yet partially mixed evidence is reported. Besides being considered as placebogenic, PMS symptoms are timely well-defined and delimited which further makes this condition attractive for an investigation of open-label placebo responses, as a possible amelioration can be measured in a delimited time frame. To sum up, a randomized controlled trial of an open-label placebo treatment of women with PMS allows to investigate ways to harness placebo effects ethically in clinical practice for syndromes with somatic and psychologically described characteristics.
- Conditions
- Premenstrual Syndrome
- Being tested
- P-Dragees rosa Lichtenstein
- Keywords
- Premenstrual Syndrome, Open-Label Placebo Effect, randomized controlled trial
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-Dragees rosa LichtensteinOther
Placebo dragées
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | The treatment as usual (TAU) group will control for regression to the mean, spontaneous remission, natural course of disease, and the participants-provider interaction. Participants of the TAU group are allowed to continue their usual medication intake, given they are already on a stable dose (at least 30 days of intake) and the medication is not listed in the exclusion criteria. |
| Integrative Open-Label Placebo | Active comparator | The intervention will encompass an integrative administration of "P-Dragees rosa Lichtenstein", which are pink placebo dragées without any active ingredient. Each dragée contents the following substances: lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; highly dispersed silicon dioxide; white clay, macrogol glycerolhydroxy stearate (Ph. Eur.); Arabic gum; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); erythrosine; aluminium salt (E 127); calcium carbonate; sucrose; glucose syrup; maize starch; macrogol 6000.
All participants will be informed that the administered dragées are placebo dragées and participants will be instructed to take two dragées a day for six weeks. (Amendment regarding dosage since 08/18) Receives: Other: P-Dragees rosa Lichtenstein |
| Open-Label Placebo | Active comparator | The intervention will encompass an administration of "P-Dragees rosa Lichtenstein", which are pink placebo dragées without any active ingredient. Each dragée contents the following substances: lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; highly dispersed silicon dioxide; white clay, macrogol glycerolhydroxy stearate (Ph. Eur.); Arabic gum; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); erythrosine; aluminium salt (E 127); calcium carbonate; sucrose; glucose syrup; maize starch; macrogol 6000.
All participants will be informed that the administered dragées are placebo dragées and participants will be instructed to take two dragées a day for six weeks. (Amendment regarding dosage since 08/18) Receives: Other: P-Dragees rosa Lichtenstein |
What is being measured
The primary outcome is the main question the study is designed to answer.
PMS symptom intensity assessed by a PMS symptom diary sub sum score
Symptom intensity will be assessed by an intensity sub scale of the PMS symptom diary. Intensity will be rated by means of a six-level Likert scale, whereat 1 is the lowest rating of symptom intensity and 6 the highest.
Measured: Continuous measurement, starting from day 1 of the menstrual cycle (length of each cycle is on average 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total)
PMS symptom interference assessed by a PMS symptom diary sub sum score
Symptom interference will be assessed by an interference sub scale of the PMS symptom diary. Interference will be rated by means of a six-level Likert scale, whereat 1 is the lowest rating of interference and 6 the highest.
Measured: Continuous measurement, starting from day 1 of the menstrual cycle (length of each cycle is on average 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total)
Secondary outcomes (1)
Experience of study participation in intervention groups
By means of semi-structured interviews, participants experience of participation in interventions groups of 10 women of the open-label placebo without treatment rationale group and of 10 women of the open-label placebo with treatment rationale group, who are randomly chosen out of the 50 participants of each of the intervention study groups will be assessed.
Measured: One time assessment, up to 2 years after baseline. The interview takes between 30 and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start2 Aug 2018
- Primary completion28 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Gaab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Gaab, University Hospital, Basel, Switzerland
- Investigators
- Jens Gaab, Prof. Dr., Principal investigator, University of Basel, Faculty of Psychology, Division for Clinical Psychology and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547661
- Sponsor's protocol ID
- ID 2017-02186
- Other IDs
- 325130_170117
- Acronym
- OLPPMS_1
- Status last verified
- Jun 2025
- First submitted
- 2 May 2018
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain. 2016 Dec;157(12):2766-2772. doi: 10.1097/j.pain.0000000000000700.
PubMed 27755279Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014 Jan 8;6(218):218ra5. doi: 10.1126/scitranslmed.3006175.
PubMed 24401940Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.
PubMed 21203519Maharaj S, Trevino K. A Comprehensive Review of Treatment Options for Premenstrual Syndrome and Premenstrual Dysphoric Disorder. J Psychiatr Pract. 2015 Sep;21(5):334-50. doi: 10.1097/PRA.0000000000000099.
PubMed 26352222O'Brien, P. S., Rapkin, A., & Schmidt, P. J. (2007). The premenstrual syndromes: PMS and PMDD: CRC Press.
Sampson GA. Premenstrual syndrome: a double-blind controlled trial of progesterone and placebo. Br J Psychiatry. 1979 Sep;135:209-15. doi: 10.1192/bjp.135.3.209.
PubMed 385093Sandler AD, Bodfish JW. Open-label use of placebos in the treatment of ADHD: a pilot study. Child Care Health Dev. 2008 Jan;34(1):104-10. doi: 10.1111/j.1365-2214.2007.00797.x.
PubMed 18171451Schaefer M, Harke R, Denke C. Open-Label Placebos Improve Symptoms in Allergic Rhinitis: A Randomized Controlled Trial. Psychother Psychosom. 2016;85(6):373-374. doi: 10.1159/000447242. Epub 2016 Oct 15. No abstract available.
PubMed 27744433Van Ree JM, Schagen Van Leeuwen JH, Koppeschaar HP, Te Velde ER. Unexpected placebo response in premenstrual dysphoric disorder: implication of endogenous opioids. Psychopharmacology (Berl). 2005 Oct;182(2):318-9. doi: 10.1007/s00213-005-0090-8. Epub 2005 Oct 19. No abstract available.
PubMed 16001107Yonkers KA, O'Brien PM, Eriksson E. Premenstrual syndrome. Lancet. 2008 Apr 5;371(9619):1200-10. doi: 10.1016/S0140-6736(08)60527-9.
PubMed 18395582Frey Nascimento A, Gaab J, Degen B, Rytz M, Holder A, Sezer D, Buergler S, Meyer AH, Kirsch I, Kossowsky J, Locher C. Efficacy of open-label placebos for premenstrual syndrome: a randomised controlled trial. BMJ Evid Based Med. 2025 Mar 25;30(5):295-304. doi: 10.1136/bmjebm-2024-112875. Online ahead of print.
PubMed 40132912Frey Nascimento A, Gaab J, Kirsch I, Kossowsky J, Meyer A, Locher C. Open-label placebo treatment of women with premenstrual syndrome: study protocol of a randomised controlled trial. BMJ Open. 2020 Feb 17;10(2):e032868. doi: 10.1136/bmjopen-2019-032868.
PubMed 32071176
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03547661
- Acronym / sponsor ID
- OLPPMS_1 / ID 2017-02186
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Syndrome, Open-Label Placebo Effect, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Jens GaabUniversity, hospital or other
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 6 Jun 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.
This study aims to investigate the effect of an open-label placebo intervention on premenstrual syndrome (PMS) complaints. Women who suffer from moderate to severe PMS will be randomly allocated to three groups: to a treatment as usual group, an open-label placebo group, and an integrative open-label placebo group. Participants of all groups will conclude a prospective PMS screening for one menstrual cycle. Thereafter, participants of both intervention groups will obtain an openly administered placebo intervention for six weeks. Participants of the treatment as usual group will have the chance to obtain the same open-label placebo intervention after study conduct. Diverse measures will be assessed by means of a PMS symptom diary and questionnaires. Furthermore, we assess participants experiences of study participation qualitatively by means of semi-structured interviews.
Detailed description
Recent evidence suggests that in certain clinical conditions - such as chronic low-back pain, migraine, irritable bowel syndrome, attention deficit hyperactivity disorder, and rhinitis - placebos improve clinical outcomes even without deception. Premenstrual syndrome (PMS) is defined as clinically significant symptoms, comprising at least one emotional or physical symptom in the premenstrual phase of the menstrual cycle and which cause substantial distress or functional impairment. To date, there exists no study examining open-label placebo responses on PMS. However, PMS seems to be considerably susceptible to placebo effects: The Royal College of Obstetricians and Gynaecologists alerts to substantial placebo responses in randomized-controlled PMS trials and studies showed considerable placebo effects on PMS without any specific effect for the medication under examination. Furthermore, a myriad of distinctive therapies is described for PMS (including pharmacological and phytopharmaceutical drugs as well as complementary non-pharmacological interventions), yet partially mixed evidence is reported. Besides being considered as placebogenic, PMS symptoms are timely well-defined and delimited which further makes this condition attractive for an investigation of open-label placebo responses, as a possible amelioration can be measured in a delimited time frame. To sum up, a randomized controlled trial of an open-label placebo treatment of women with PMS allows to investigate ways to harness placebo effects ethically in clinical practice for syndromes with somatic and psychologically described characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –The treatment as usual (TAU) group will control for regression to the mean, spontaneous remission, natural course of disease, and the participants-provider interaction. Participants of the TAU group are allowed to continue their usual medication intake, given they are already on a stable dose (at least 30 days of intake) and the medication is not listed in the exclusion criteria. |
| Integrative Open-Label Placebo | Active comparator | Other: P-Dragees rosa LichtensteinThe intervention will encompass an integrative administration of "P-Dragees rosa Lichtenstein", which are pink placebo dragées without any active ingredient. Each dragée contents the following substances: lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; highly dispersed silicon dioxide; white clay, macrogol glycerolhydroxy stearate (Ph. Eur.); Arabic gum; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); erythrosine; aluminium salt (E 127); calcium carbonate; sucrose; glucose syrup; maize starch; macrogol 6000. All participants will be informed that the administered dragées are placebo dragées and participants will be instructed to take two dragées a day for six weeks. (Amendment regarding dosage since 08/18) |
| Open-Label Placebo | Active comparator | Other: P-Dragees rosa LichtensteinThe intervention will encompass an administration of "P-Dragees rosa Lichtenstein", which are pink placebo dragées without any active ingredient. Each dragée contents the following substances: lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; highly dispersed silicon dioxide; white clay, macrogol glycerolhydroxy stearate (Ph. Eur.); Arabic gum; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); erythrosine; aluminium salt (E 127); calcium carbonate; sucrose; glucose syrup; maize starch; macrogol 6000. All participants will be informed that the administered dragées are placebo dragées and participants will be instructed to take two dragées a day for six weeks. (Amendment regarding dosage since 08/18) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Moderate to severe PMS
- Between 18 and 45 years of age
- A regular menstrual cycle, i.e., max. +/- 3 days of difference of cycle range
- Menstrual cycle range not longer than 31 or shorter than 24 days
- Participants have a general practioner or gynaecologist to consult
Key exclusion criteria (12 listed)
- Brest feeding at the moment or during the last three months
- Pregnancy
- Failing menstruation onset in the course of two consecutive menstrual cycles
- An essential mental or somatic disease
- Drug or massive alcohol intake or of other psychoactive substances
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 |
|---|---|---|
| P-Dragees rosa LichtensteinPlacebo dragées | Other | Integrative Open-Label Placebo, Open-Label Placebo |
Primary outcome
PMS symptom intensity assessed by a PMS symptom diary sub sum score
Time frame: Continuous measurement, starting from day 1 of the menstrual cycle (length of each cycle is on average 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total)
Symptom intensity will be assessed by an intensity sub scale of the PMS symptom diary. Intensity will be rated by means of a six-level Likert scale, whereat 1 is the lowest rating of symptom intensity and 6 the highest.
PMS symptom interference assessed by a PMS symptom diary sub sum score
Time frame: Continuous measurement, starting from day 1 of the menstrual cycle (length of each cycle is on average 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total)
Symptom interference will be assessed by an interference sub scale of the PMS symptom diary. Interference will be rated by means of a six-level Likert scale, whereat 1 is the lowest rating of interference and 6 the highest.
1 secondary outcome
Experience of study participation in intervention groups
Time frame: One time assessment, up to 2 years after baseline. The interview takes between 30 and 60 minutes
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 5 Jun 2025.
- Background: PubMed 27755279Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain. 2016 Dec;157(12):2766-2772. doi: 10.1097/j.pain.0000000000000700.
- Background: PubMed 24401940Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014 Jan 8;6(218):218ra5. doi: 10.1126/scitranslmed.3006175.
- Background: PubMed 21203519Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.
- Background: PubMed 26352222Maharaj S, Trevino K. A Comprehensive Review of Treatment Options for Premenstrual Syndrome and Premenstrual Dysphoric Disorder. J Psychiatr Pract. 2015 Sep;21(5):334-50. doi: 10.1097/PRA.0000000000000099.
- BackgroundO'Brien, P. S., Rapkin, A., & Schmidt, P. J. (2007). The premenstrual syndromes: PMS and PMDD: CRC Press.
- Background: PubMed 385093Sampson GA. Premenstrual syndrome: a double-blind controlled trial of progesterone and placebo. Br J Psychiatry. 1979 Sep;135:209-15. doi: 10.1192/bjp.135.3.209.
- Background: PubMed 18171451Sandler AD, Bodfish JW. Open-label use of placebos in the treatment of ADHD: a pilot study. Child Care Health Dev. 2008 Jan;34(1):104-10. doi: 10.1111/j.1365-2214.2007.00797.x.
- Background: PubMed 27744433Schaefer M, Harke R, Denke C. Open-Label Placebos Improve Symptoms in Allergic Rhinitis: A Randomized Controlled Trial. Psychother Psychosom. 2016;85(6):373-374. doi: 10.1159/000447242. Epub 2016 Oct 15. No abstract available.
- Background: PubMed 16001107Van Ree JM, Schagen Van Leeuwen JH, Koppeschaar HP, Te Velde ER. Unexpected placebo response in premenstrual dysphoric disorder: implication of endogenous opioids. Psychopharmacology (Berl). 2005 Oct;182(2):318-9. doi: 10.1007/s00213-005-0090-8. Epub 2005 Oct 19. No abstract available.
- Background: PubMed 18395582Yonkers KA, O'Brien PM, Eriksson E. Premenstrual syndrome. Lancet. 2008 Apr 5;371(9619):1200-10. doi: 10.1016/S0140-6736(08)60527-9.
- Results publication: PubMed 40132912Frey Nascimento A, Gaab J, Degen B, Rytz M, Holder A, Sezer D, Buergler S, Meyer AH, Kirsch I, Kossowsky J, Locher C. Efficacy of open-label placebos for premenstrual syndrome: a randomised controlled trial. BMJ Evid Based Med. 2025 Mar 25;30(5):295-304. doi: 10.1136/bmjebm-2024-112875. Online ahead of print.
- Derived from this study: PubMed 32071176Frey Nascimento A, Gaab J, Kirsch I, Kossowsky J, Meyer A, Locher C. Open-label placebo treatment of women with premenstrual syndrome: study protocol of a randomised controlled trial. BMJ Open. 2020 Feb 17;10(2):e032868. doi: 10.1136/bmjopen-2019-032868.
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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.
Jens Gaab, Prof. Dr. principal investigator
University of Basel, Faculty of Psychology, Division for Clinical Psychology and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P-Dragees rosa Lichtenstein in people with Premenstrual Syndrome, run by Jens Gaab at 1 site in Switzerland.
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 6 inclusion and 12 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 5 Jun 2025. 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 Switzerland. 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. 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?
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?
PMS symptom intensity assessed by a PMS symptom diary sub sum score (time frame: Continuous measurement, starting from day 1 of the menstrual cycle (length of each cycle is on average 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total)). The study lists 2 primary outcomes in all. 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 NCT03547661, which also lists 12 linked publications.
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 5 Jun 2025.