EndometriosisAsh_EndNCT07898670
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
A study testing Ashwagandha in people with Endometriosis and Quality of Life, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The goal of this clinical trial is to learn how ashwagandha, a herbal dietary supplement, affects quality of life in women with endometriosis. Researchers will also assess how well participants tolerate it. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Endometriosis, Quality of Life, Pain
- What is being tested?
- Ashwagandha
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent given by participants after being provided detailed information about the nature, risks, and scope of the study
- Premenopausal women aged 18-51 years.
- Clinically confirmed diagnosis of endometriosis by laparoscopy within the past 10 years, ultrasound, and/or imaging (TVUS/MRI) showing endometrioma, adenomyosis, or deep-infiltrating endometriosis within 6 months.
- EHP-30 score of more than 40.
- Participant-reported pelvic pain, defined as dysmenorrhea and/or non-menstrual pelvic pain of ≥4 on NRS on at least 5 days during a 28-day screening phase
- If sexually active and of childbearing potential: agreement to use a highly effective non- hormonal double-barrier method (e.g., condom plus diaphragm, condom plus spermicide, copper intrauterine device, or partner vasectomy)
- Ability to provide informed consent and complete questionnaires.
Who cannot join
- current or recent use of oral hormonal therapies within 4 weeks before screening
- use of hormonal depot therapy within 3 months before screening
- hysterectomy, bilateral oophorectomy, or endometrial ablation resulting in amenorrhea
- pregnancy, lactation, or pregnancy planned during the study period
- history of liver disease or clinically relevant liver injury of any cause, including viral, alcohol-related, or autoimmune
- abnormal liver function tests (ALT, AST, or bilirubin above the upper limit of normal) at screening
Show all 13Show fewer
- severe renal impairment
- active autoimmune disease or malignant disease
- use of systemic immunosuppressants or glucocorticoids within the last 3 months
- use of supplements containing Ashwagandha, curcumin, or other adaptogens or anti- inflammatory supplements within 4 weeks before screening
- hypersensitivity to herbal products or study excipients
- participation in another clinical trial within the last 1 month
- any other objection to participation in the opinion of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Department of Clinical Pharmacology, Medical University Vienna, Vienna General Hospital
Vienna, 1090
Melissa Seven, MD, +43140400 ext. 29810, klin-pharmakologie@meduniwien.ac.at
About this study
Official title: An Exploratory Study of Participant-reported Well- Being During Ashwagandha Supplementation in Women With Endometriosis
The goal of this clinical trial is to learn how ashwagandha, a herbal dietary supplement, affects quality of life in women with endometriosis. Researchers will also assess how well participants tolerate it.
The main questions are:
Read more
- Does ashwagandha affect mental well-being and quality of life compared with placebo?
- Does it affect physical health, perceived stress, or endometriosis-related quality of life?
- Does it affect pain during intercourse or how participants manage pain, including pain medication use?
- What side effects or changes in blood test results occur during supplementation?
Researchers will compare ashwagandha with a placebo, a look-alike capsule containing no active ingredient. The study will include 90 women. A chance process will assign participants to a group. Each participant has a two-in-three chance of receiving ashwagandha. Neither participants nor researchers assessing the results will know who receives ashwagandha during this phase.
Participants will:
- Take 300 mg of ashwagandha or placebo daily for 12 weeks. This may extend to 16 weeks to match assessments with the menstrual cycle.
- Complete questionnaires about quality of life, stress, pain during intercourse, and pain management.
- Attend regular clinic visits for health checks and blood tests.
- Attend a follow-up visit about four weeks after finishing the study capsules.
After the first phase, eligible participants may choose to continue for another 12 weeks. Everyone in this optional phase will take ashwagandha and know they are taking it. Researchers will track further changes in quality of life, stress, and side effects.
Participants will continue their usual care for endometriosis. Whether ashwagandha benefits women with endometriosis is not yet known.
Read the detailed description
Women with endometriosis frequently experience reduced quality of life, increased perceived stress, fatigue, and sleep disturbances. Ashwagandha (Withania somnifera) has been investigated for its effects on stress and well-being in other populations, but its effects in women with endometriosis remain uncertain. This exploratory study evaluates its use as a dietary supplement alongside standard care. The initial randomized, placebo-controlled phase will provide the controlled comparison. Assessments will be aligned with the menstrual cycle where feasible to account for cycle-related fluctuations in participant-reported outcomes. The optional open-label extension will provide descriptive information on longer-term tolerability and within-participant changes. Extension outcomes will be analysed separately according to initial treatment allocation to explore whether changes are maintained in participants initially assigned to ashwagandha and whether changes emerge in those initially assigned to placebo. As there is no placebo comparison during the extension, these findings will be interpreted descriptively. Additional blood samples will be stored for potential future research. Analyses of stored samples will require separate ethics committee approval.
- Conditions
- Endometriosis, Quality of Life, Pain, Perceived Stress, Psychological Well Being
- Being tested
- Ashwagandha, placebo capsule
- Keywords
- Endometriosis, Ashwagandha, Withania somnifera, Health-related quality of life, Perceived stress, Psychological well-being, Pelvic Pain
- Medical subject headings
- Endometriosis, Pain, Psychological Well-Being, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AshwagandhaDietary supplement
The product is commercially available as the root and leaf extract, SHODEN®, 300 mg per capsule, standardized to at least 30% withanolides.
placebo capsuleDrug
Matching placebo (capsules containing an inert filler, identical in appearance, taste, and smell to the active study product)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants take a matching placebo orally once daily for 12 weeks. The initial phase may be extended to a maximum of 16 weeks to align assessments with the menstrual cycle. Eligible participants may then enter an optional open-label extension and switch to ashwagandha 300 mg orally once daily for a further 12 weeks. Receives: Drug: placebo capsule |
| Ashwagandha | Experimental | Participants take ashwagandha 300 mg orally once daily for 12 weeks. The initial phase may be extended to a maximum of 16 weeks to align assessments with the menstrual cycle. Eligible participants may then enter an optional open-label extension and continue ashwagandha 300 mg orally once daily for a further 12 weeks. Receives: Dietary Supplement: Ashwagandha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) score
Between-group difference in change from baseline to the end of the initial randomized phase in the SF-36 Mental Component Summary (MCS) score, comparing ashwagandha with placebo. The MCS assesses mental health-related quality of life and is calculated using a standardized, norm-based scoring algorithm, with a reference population mean of 50 and a standard deviation of 10. Higher scores indicate better mental health-related quality of life.
Measured: Baseline and end of the initial randomized phase at 12 weeks (up to 16 weeks if extended to align with the menstrual cycle).
Secondary outcomes (11)
Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) score
Between-group difference in change from baseline to the end of the initial randomized phase in the SF-36 Physical Component Summary (PCS) score, comparing ashwagandha with placebo. The PCS assesses physical health-related quality of life and is calculated using a standardized, norm-based scoring algorithm, with a reference population mean of 50 and a standard deviation of 10. Higher scores indicate better physical health-related quality of life.
Measured: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle).
Change in 36-Item Short Form Health Survey (SF-36) domain scores
Between-group differences in change from baseline to the end of the initial randomized phase in the eight domains of the 36-Item Short Form Health Survey (SF-36), comparing ashwagandha with placebo: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Each domain is scored separately on a scale from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle).
Change in Endometriosis Health Profile-30 global score
Between-group difference in change from baseline to the end of the initial randomized phase in endometriosis-related quality of life, assessed using the Endometriosis Health Profile-30 (EHP-30) global score, comparing ashwagandha with placebo. Scores range from 0 to 100, with lower scores indicating better endometriosis-related quality of life.
Measured: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle).
Change in perceived stress
Between-group difference in change from baseline to the end of the initial randomized phase in perceived stress, assessed using the 10-item Perceived Stress Scale (PSS-10), comparing ashwagandha with placebo. The total score ranges from 0 to 40, with higher scores indicating greater perceived stress.
Measured: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle).
Participant-reported pain-management strategies and pain medication use
Comparison between the ashwagandha and placebo groups of participant-reported pain-management strategies, including total pain medication (name, number, dosage) use during the menstrual cycle.
Measured: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle).
Change in participant-reported dyspareunia
Between-group difference in change from baseline to the end of the initial randomized phase in participant-reported pain during sexual intercourse (dyspareunia), comparing ashwagandha with placebo. Pain intensity is assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
Measured: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle).
Within-person change in the 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) during the open-label extension
Within-person change in the SF-36 Mental Component Summary (MCS) score from the start to the end of the open-label extension, during which participants receive ashwagandha. The MCS assesses mental health-related quality of life and is calculated using a standardized, norm-based scoring algorithm, with a reference population mean of 50 and a standard deviation of 10. Higher scores indicate better mental health-related quality of life.
Measured: Start of the open-label extension to its completion 12 weeks later (approximately study Week 12-24, or Week 16-28 if the initial phase is extended).
Within-person change in the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS ) during the open-label extension
Within-person change in the SF-36 Physical Component Summary (PCS) score from the start to the end of the open-label extension, during which participants receive ashwagandha. The PCS assesses physical health-related quality of life and is calculated using a standardized, norm-based scoring algorithm, with a reference population mean of 50 and a standard deviation of 10. Higher scores indicate better physical health-related quality of life.
Measured: Start of the open-label extension to its completion 12 weeks later (approximately study Week 12-24, or Week 16-28 if the initial phase is extended).
Within-person change in the Endometriosis Health Profile-30 (EHP-30) during the open-label extension
Within-person change in the Endometriosis Health Profile-30 (EHP-30) global score from the start to the end of the open-label extension, during which participants receive ashwagandha. The EHP-30 assesses endometriosis-related quality of life. Scores range from 0 to 100, with lower scores indicating better endometriosis-related quality of life.
Measured: Start of the open-label extension to its completion 12 weeks later (approximately study Week 12-24, or Week 16-28 if the initial phase is extended).
Within-person change in the 10-item Perceived Stress Scale (PSS-10) during the open-label extension
Within-person change in the PSS-10 total score from the start to the end of the open-label extension, during which participants receive ashwagandha. The PSS-10 assesses perceived stress. The total score ranges from 0 to 40, with higher scores indicating greater perceived stress.
Measured: Start of the open-label extension to its completion 12 weeks later (approximately study Week 12-24, or Week 16-28 if the initial phase is extended).
Tolerability (Occurrence of clinical adverse events and laboratory abnormalities)
Number of participants experiencing clinical adverse events, with events summarized by frequency and severity; clinically relevant laboratory abnormalities, assessed through scheduled safety blood tests.
Measured: From the first study dose through approximately four weeks after the last dose, up to approximately 32 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startNov 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernd Jilma, Medical University of Vienna
- Investigators
- Bernd Jilma, Professor, MD, Principal investigator, Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898670
- Sponsor's protocol ID
- EC Nr. 1776/2026
- Acronym
- Ash_End
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data with researchers outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Participant-reported Well- Being During Ashwagandha Supplementation in Women With Endometriosis
- ClinicalTrials.gov ID
- NCT07898670
- Acronym / sponsor ID
- Ash_End / EC Nr. 1776/2026
- Conditions
- Endometriosis, Quality of Life, Pain, Perceived Stress, Psychological Well Being
- Keywords
- Endometriosis, Ashwagandha, Withania somnifera, Health-related quality of life, Perceived stress, Psychological well-being, Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 27 Oct 2026 (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 goal of this clinical trial is to learn how ashwagandha, a herbal dietary supplement, affects quality of life in women with endometriosis. Researchers will also assess how well participants tolerate it.
The main questions are:
- Does ashwagandha affect mental well-being and quality of life compared with placebo?
- Does it affect physical health, perceived stress, or endometriosis-related quality of life?
- Does it affect pain during intercourse or how participants manage pain, including pain medication use?
- What side effects or changes in blood test results occur during supplementation?
Researchers will compare ashwagandha with a placebo, a look-alike capsule containing no active ingredient. The study will include 90 women. A chance process will assign participants to a group. Each participant has a two-in-three chance of receiving ashwagandha. Neither participants nor researchers assessing the results will know who receives ashwagandha during this phase.
Participants will:
- Take 300 mg of ashwagandha or placebo daily for 12 weeks. This may extend to 16 weeks to match assessments with the menstrual cycle.
- Complete questionnaires about quality of life, stress, pain during intercourse, and pain management.
- Attend regular clinic visits for health checks and blood tests.
- Attend a follow-up visit about four weeks after finishing the study capsules.
After the first phase, eligible participants may choose to continue for another 12 weeks. Everyone in this optional phase will take ashwagandha and know they are taking it. Researchers will track further changes in quality of life, stress, and side effects.
Participants will continue their usual care for endometriosis. Whether ashwagandha benefits women with endometriosis is not yet known.
Detailed description
Women with endometriosis frequently experience reduced quality of life, increased perceived stress, fatigue, and sleep disturbances. Ashwagandha (Withania somnifera) has been investigated for its effects on stress and well-being in other populations, but its effects in women with endometriosis remain uncertain. This exploratory study evaluates its use as a dietary supplement alongside standard care. The initial randomized, placebo-controlled phase will provide the controlled comparison. Assessments will be aligned with the menstrual cycle where feasible to account for cycle-related fluctuations in participant-reported outcomes. The optional open-label extension will provide descriptive information on longer-term tolerability and within-participant changes. Extension outcomes will be analysed separately according to initial treatment allocation to explore whether changes are maintained in participants initially assigned to ashwagandha and whether changes emerge in those initially assigned to placebo. As there is no placebo comparison during the extension, these findings will be interpreted descriptively. Additional blood samples will be stored for potential future research. Analyses of stored samples will require separate ethics committee approval.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placebo capsuleParticipants take a matching placebo orally once daily for 12 weeks. The initial phase may be extended to a maximum of 16 weeks to align assessments with the menstrual cycle. Eligible participants may then enter an optional open-label extension and switch to ashwagandha 300 mg orally once daily for a further 12 weeks. |
| Ashwagandha | Experimental | Dietary Supplement: AshwagandhaParticipants take ashwagandha 300 mg orally once daily for 12 weeks. The initial phase may be extended to a maximum of 16 weeks to align assessments with the menstrual cycle. Eligible participants may then enter an optional open-label extension and continue ashwagandha 300 mg orally once daily for a further 12 weeks. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent given by participants after being provided detailed information about the nature, risks, and scope of the study
- Premenopausal women aged 18-51 years.
- Clinically confirmed diagnosis of endometriosis by laparoscopy within the past 10 years, ultrasound, and/or imaging (TVUS/MRI) showing endometrioma, adenomyosis, or deep-infiltrating endometriosis within 6 months.
- EHP-30 score of more than 40.
- Participant-reported pelvic pain, defined as dysmenorrhea and/or non-menstrual pelvic pain of ≥4 on NRS on at least 5 days during a 28-day screening phase
Key exclusion criteria (13 listed)
- current or recent use of oral hormonal therapies within 4 weeks before screening
- use of hormonal depot therapy within 3 months before screening
- hysterectomy, bilateral oophorectomy, or endometrial ablation resulting in amenorrhea
- pregnancy, lactation, or pregnancy planned during the study period
- history of liver disease or clinically relevant liver injury of any cause, including viral, alcohol-related, or autoimmune
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 |
|---|---|---|
| AshwagandhaThe product is commercially available as the root and leaf extract, SHODEN®, 300 mg per capsule, standardized to at least 30% withanolides. | Dietary supplement | Ashwagandha |
| placebo capsuleMatching placebo (capsules containing an inert filler, identical in appearance, taste, and smell to the active study product) | Drug | Placebo |
Primary outcome
Change from baseline in the 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) score
Time frame: Baseline and end of the initial randomized phase at 12 weeks (up to 16 weeks if extended to align with the menstrual cycle).
Between-group difference in change from baseline to the end of the initial randomized phase in the SF-36 Mental Component Summary (MCS) score, comparing ashwagandha with placebo. The MCS assesses mental health-related quality of life and is calculated using a standardized, norm-based scoring algorithm, with a reference population mean of 50 and a standard deviation of 10. Higher scores indicate better mental health-related quality of life.
11 secondary outcomes
Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) score
Time frame: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle).
Change in 36-Item Short Form Health Survey (SF-36) domain scores
Time frame: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle).
Change in Endometriosis Health Profile-30 global score
Time frame: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle).
Change in perceived stress
Time frame: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle).
Participant-reported pain-management strategies and pain medication use
Time frame: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle).
Change in participant-reported dyspareunia
Time frame: Baseline to the end of the initial randomized phase at Week 12 (up to Week 16 if extended to align assessments with the menstrual cycle).
Within-person change in the 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) during the open-label extension
Time frame: Start of the open-label extension to its completion 12 weeks later (approximately study Week 12-24, or Week 16-28 if the initial phase is extended).
Within-person change in the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS ) during the open-label extension
Time frame: Start of the open-label extension to its completion 12 weeks later (approximately study Week 12-24, or Week 16-28 if the initial phase is extended).
Within-person change in the Endometriosis Health Profile-30 (EHP-30) during the open-label extension
Time frame: Start of the open-label extension to its completion 12 weeks later (approximately study Week 12-24, or Week 16-28 if the initial phase is extended).
Within-person change in the 10-item Perceived Stress Scale (PSS-10) during the open-label extension
Time frame: Start of the open-label extension to its completion 12 weeks later (approximately study Week 12-24, or Week 16-28 if the initial phase is extended).
Tolerability (Occurrence of clinical adverse events and laboratory abnormalities)
Time frame: From the first study dose through approximately four weeks after the last dose, up to approximately 32 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data with researchers outside the study team.
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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.
Bernd Jilma, Professor, MD principal investigator
Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ashwagandha in people with Endometriosis and Quality of Life, run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 13 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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 Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Seven, MD (+43140400 ext. 29810, klin-pharmakologie@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) score (time frame: Baseline and end of the initial randomized phase at 12 weeks (up to 16 weeks if extended to align with the menstrual cycle).). 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 27 Oct 2026.