Polycystic Ovarian SyndromePhase 2NCT02729545

The Efficacy and Safety Study of Tung's Acupuncture for Polycystic Ovarian Syndrome

A Phase 2 study testing Tung's acupuncture and Cyproterone acetate/ethinylestradiol (CPA/EE) in people with Polycystic Ovarian Syndrome, run by Beijing Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the efficacy and safety in improving ovarian function of polycystic ovarian syndrome in adults. Half of patients will receive Tung's acupuncture therapy, while the other half will receive Diane-35(CPA/EE) as the control group. Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Polycystic Ovarian Syndrome
What is being tested?: Tung's acupuncture and Cyproterone acetate/ethinylestradiol (CPA/EE)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: Apr 2016to May 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Chinese;
18-45 years old;
to meet the diagnostic criteria for polycystic ovary syndrome;
no need for pregnancy in the next six months;
volunteering to join this research and give informed consent prior to receiving treatment.

Who cannot join

hypertensive patients with blood pressure exceed 160/100 mmHg;
a history of thrombosis,cerebrolvascular diseases, cancer, liver disease or liver dysfuction, hyperlipidemia, mental disorder, and severe infection;
having taken any pharmacological treatments affecting reproductive endocrine system;
having received acupuncture in the previous three months;
smoking more than 15 cigarettes per day;
having pacemakers, metal allergies or severe fear of acupuncture.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Beijing, Beijing Municipality, 100039

Other trials in China

About this study

Official title: The Efficacy and Safety Study of Tung's Acupuncture for Improving Ovarian Function of Polycystic Ovarian Syndrome: a Randomised Controlled Trial

Read the detailed description

Both Tung's acupuncture therapy and Diane-35(CPA/EE) could improve the symptom of patients with polycystic ovarian syndrome, but until now there is no definite evidence to indicate acupuncture could play the same role in improving ovarian function. So we design this study to observe the change of follicular development, ovary size and sex hormone( testosterone, follitropin, luteinizing hormone) before and after the treatment, and evaluate the efficacy and safty of acupuncture.

Conditions: Polycystic Ovarian Syndrome
Being tested: Tung's acupuncture, Cyproterone acetate/ethinylestradiol (CPA/EE)
Keywords: acupuncture, LH/FSH, total testosterone (TT), polycystic ovarian syndrome(PCOS)
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.

Tung's acupunctureOther
The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).
Cyproterone acetate/ethinylestradiol (CPA/EE)Drug
Also called Diane-35
Cyproterone acetate/ethinylestradiol (CPA/EE) contains 2mg cyproterone acetate (an anti-androgenic progestin) and 0.035mg ethinylestradiol (CPA/EE). The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).

Study groups in NCT02729545
Study group	Role	What they receive
Tung's acupuncture	Experimental	The Tung's acupuncture group received acupuncture treatments twice per week for 12 weeks. The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1). Receives: Other: Tung's acupuncture
CPA/EE	Active comparator	Cyproterone acetate/ethinylestradiol (CPA/EE) was taken orally one tablet per day from the 8th day of menstrual cycle or any day for patients with amenorrhea. The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles). Receives: Drug: Cyproterone acetate/ethinylestradiol (CPA/EE)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in LH/FSH Ratio From Baseline to the End of Treatment
the change in LH/FSH ratio, values after 12-week treatment minus the values at baseline
Measured: baseline and 12 weeks

Secondary outcomes (8)

Change in LH/FSH Ratio From Baseline to the 24th Week
the change in LH/FSH ratio, values at the 24th week minus the values at baseline
Measured: baseline to the 24th week
Changes in LH From Baseline to the End of Treatment
changes in luteinizing hormone(LH), values after 12-week treatment minus the values at baseline
Measured: baseline and 12 weeks
Changes in FSH From Baseline to the End of Treatment
changes in follicle-stimulating hormone (FSH), values after 12-week treatment minus the values at baseline
Measured: baseline and 12 weeks
Changes in Body Mass Index (BMI) From Baseline to the End of Treatment
the changes in BMI, values after 12-week treatment minus the values at baseline
Measured: baseline and 12 weeks
Changes in Total Testosterone (TT) From Baseline to the End of Treatment
changes in total testosterone (TT) , values after 12-week treatment minus the values at baseline
Measured: baseline and 12 weeks
Changes in Ovarian Volume From Baseline to the End of Treatment
changes in ovarian volume, values after 12-week treatment minus the values at baseline
Measured: baseline and 12 weeks
Changes in Polycystic Ovary Number From Baseline to the End of Treatment
the changes in polycystic ovary number, values after 12-week treatment minus the values at baseline
Measured: baseline and 12 weeks
Changes in the Number of Bleeding Events From Baseline to the End of Treatment
Changes in the number of bleeding events, values after 12-week treatment minus the values at baseline
Measured: baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016May 2018

First posted6 Apr 2016 (estimated)
Study startApr 2016
Primary completionMar 2018
Study completionMay 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Polycystic Ovarian 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study was a randomized, drug-controlled, and parallel group trial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02729545
Sponsor's protocol ID: JJ2015-42
Status last verified: Sep 2019
First submitted: 29 Mar 2016
Last updated: 8 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: to share data by publishing paper

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)

All Polycystic Ovarian Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety Study of Tung's Acupuncture for Improving Ovarian Function of Polycystic Ovarian Syndrome: a Randomised Controlled Trial
ClinicalTrials.gov ID: NCT02729545
Acronym / sponsor ID: JJ2015-42
Conditions: Polycystic Ovarian Syndrome
Keywords: acupuncture, LH/FSH, total testosterone (TT), polycystic ovarian syndrome(PCOS)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Beijing Hospital of Integrated Traditional Chinese and Western MedicineUniversity, hospital or other
Study start: Apr 2016 (actual)
Primary completion: Mar 2018 (actual)
Study completion: May 2018 (actual)
First posted: 6 Apr 2016 (estimated)
Results: Posted 24 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: The study was a randomized, drug-controlled, and parallel group trial

Arm	Type	Receives
Tung's acupuncture	Experimental	Other: Tung's acupunctureThe Tung's acupuncture group received acupuncture treatments twice per week for 12 weeks. The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).
CPA/EE	Active comparator	Drug: Cyproterone acetate/ethinylestradiol (CPA/EE)Cyproterone acetate/ethinylestradiol (CPA/EE) was taken orally one tablet per day from the 8th day of menstrual cycle or any day for patients with amenorrhea. The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Chinese;
18-45 years old;
to meet the diagnostic criteria for polycystic ovary syndrome;
no need for pregnancy in the next six months;
volunteering to join this research and give informed consent prior to receiving treatment.

Key exclusion criteria (6 listed)

hypertensive patients with blood pressure exceed 160/100 mmHg;
a history of thrombosis,cerebrolvascular diseases, cancer, liver disease or liver dysfuction, hyperlipidemia, mental disorder, and severe infection;
having taken any pharmacological treatments affecting reproductive endocrine system;
having received acupuncture in the previous three months;
smoking more than 15 cigarettes per day;

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
Tung's acupunctureThe study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).	Other	Tung's acupuncture
Cyproterone acetate/ethinylestradiol (CPA/EE)Also: Diane-35Cyproterone acetate/ethinylestradiol (CPA/EE) contains 2mg cyproterone acetate (an anti-androgenic progestin) and 0.035mg ethinylestradiol (CPA/EE). The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).	Drug	CPA/EE

Primary outcome

Change in LH/FSH Ratio From Baseline to the End of Treatment
Time frame: baseline and 12 weeks
the change in LH/FSH ratio, values after 12-week treatment minus the values at baseline

8 secondary outcomes

Change in LH/FSH Ratio From Baseline to the 24th Week
Time frame: baseline to the 24th week
Changes in LH From Baseline to the End of Treatment
Time frame: baseline and 12 weeks
Changes in FSH From Baseline to the End of Treatment
Time frame: baseline and 12 weeks
Changes in Body Mass Index (BMI) From Baseline to the End of Treatment
Time frame: baseline and 12 weeks
Changes in Total Testosterone (TT) From Baseline to the End of Treatment
Time frame: baseline and 12 weeks
Changes in Ovarian Volume From Baseline to the End of Treatment
Time frame: baseline and 12 weeks
Changes in Polycystic Ovary Number From Baseline to the End of Treatment
Time frame: baseline and 12 weeks
Changes in the Number of Bleeding Events From Baseline to the End of Treatment
Time frame: baseline and 12 weeks

Results and safety

Results posted to the registry on 24 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tung's Acupuncture Group	30	27
CPA/EE Group	30	25

Primary outcome: Change in LH/FSH Ratio From Baseline to the End of Treatment

Time frame: baseline and 12 weeks. Mean (95% Confidence Interval). Unit: ratio

Measure	Tung's Acupuncture n = 29	CPA/EE n = 28
Value	-0.66 (-1.03 to -0.28)	-0.96 (-1.34 to -0.59)

Population analysed: Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tung's Acupuncture Group	0 of 30 (0%)	5 of 30 (16.7%)	0 of 30
CPA/EE Group	0 of 30 (0%)	4 of 30 (13.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. to share data by publishing paper

Related trials for Polycystic Ovarian Syndrome

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)

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.

Zhishun Liu, Doctor study director

Guang'anmen Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 6 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 8 Oct 2019. 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 China. 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.

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?

Yes. Results are posted in the registry (first posted 24 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in LH/FSH Ratio From Baseline to the End of Treatment (time frame: baseline and 12 weeks). 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 NCT02729545.

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 8 Oct 2019.