Polycystic Ovary SyndromeNCT06158932
A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance
A study testing Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement in people with Polycystic Ovary Syndrome and Hormone Imbalance, run by Optify at 1 site in United States.
Trial summary
This is a virtual single group study that will last 12 weeks. 40 female participants will take 4 capsules of the Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement per day. Questionnaires will be completed at Baseline, Week 4, Week 8 and Week 12. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Hormone Imbalance
- What is being tested?
- Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2023to 6 Jan 2024
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged between 18 - 55
- BMI less than 35
- Self-reported symptoms of PCOS like irregular periods, excessive hair growth, weight gain, oily skin, or acne
- Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy
- Self-reported concerns with hormonal skin issues
- Has access to a tape measure for waist measurement
- Generally healthy - don't live with any uncontrolled chronic disease
Who cannot join
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Anyone with known severe allergic reactions
- Anyone who is pregnant or breastfeeding
- Unwilling to follow the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
This is a virtual single group study that will last 12 weeks. 40 female participants will take 4 capsules of the Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement per day. Questionnaires will be completed at Baseline, Week 4, Week 8 and Week 12. Participants will also provide a waist circumference measurement at Baseline and Week 12.
- Conditions
- Polycystic Ovary Syndrome, Hormone Imbalance
- Being tested
- Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplementDietary supplement
This product contains Myo-Inositol, D-Chiro-Inositol, Folate and Vitamin D.
| Study group | Role | What they receive |
|---|---|---|
| Myo Inositol and D-Chiro Inositol Supplement | Experimental | Participants must take 4 capsules per day, with water. The product should be taken with the last meal of the day. Receives: Dietary Supplement: Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in menstrual cycle regularity. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires with participants reporting menstrual cycle occurrence and regularity during the trial.
Measured: 12 weeks
Changes in severity of menstrual cramps. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 12 weeks
Changes in hormonal skin issues. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 12 weeks
Changes in excessive body hair or facial hair. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 12 weeks
Secondary outcomes (5)
Changes in mood. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 12 weeks
Changes in stress. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 12 weeks
Changes in food cravings. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 12 weeks
Changes in sleep quality. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 12 weeks
Changes in energy. [Timeframe: Baseline to Week 12]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start8 Sep 2023
- Primary completion6 Jan 2024
- Study completion6 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optify
- Sponsor type
- University, hospital or other
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158932
- Sponsor's protocol ID
- 20366
- Status last verified
- Apr 2024
- First submitted
- 28 Nov 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance
- ClinicalTrials.gov ID
- NCT06158932
- Acronym / sponsor ID
- 20366
- Conditions
- Polycystic Ovary Syndrome, Hormone Imbalance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- OptifyUniversity, hospital or other
- Collaborators
- Citruslabs
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 6 Jan 2024 (actual)
- Study completion
- 6 Jan 2024 (actual)
- First posted
- 6 Dec 2023 (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 is a virtual single group study that will last 12 weeks. 40 female participants will take 4 capsules of the Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement per day. Questionnaires will be completed at Baseline, Week 4, Week 8 and Week 12. Participants will also provide a waist circumference measurement at Baseline and Week 12.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myo Inositol and D-Chiro Inositol Supplement | Experimental | Dietary Supplement: Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplementParticipants must take 4 capsules per day, with water. The product should be taken with the last meal of the day. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women aged between 18 - 55
- BMI less than 35
- Self-reported symptoms of PCOS like irregular periods, excessive hair growth, weight gain, oily skin, or acne
- Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy
- Self-reported concerns with hormonal skin issues
Key exclusion criteria (4 listed)
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Anyone with known severe allergic reactions
- Anyone who is pregnant or breastfeeding
- Unwilling to follow the study protocol
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 |
|---|---|---|
| Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplementThis product contains Myo-Inositol, D-Chiro-Inositol, Folate and Vitamin D. | Dietary supplement | Myo Inositol and D-Chiro Inositol Supplement |
Primary outcome
Changes in menstrual cycle regularity. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Measured via study-specific questionnaires with participants reporting menstrual cycle occurrence and regularity during the trial.
Changes in severity of menstrual cramps. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Changes in hormonal skin issues. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Changes in excessive body hair or facial hair. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
5 secondary outcomes
Changes in mood. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Changes in stress. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Changes in food cravings. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Changes in sleep quality. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Changes in energy. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
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 3 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement in people with Polycystic Ovary Syndrome and Hormone Imbalance, run by Optify 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 7 inclusion and 4 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 3 Apr 2024. 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. 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?
Changes in menstrual cycle regularity. [Timeframe: Baseline to Week 12] (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 3 Apr 2024.