PerimenopausePhase 2/3NCT01933204
Acupuncture for Relieving Perimenopausal Symptoms
A Phase 2/3 study testing Acupuncture and Climen 21 Tablets in people with Perimenopause, run by Chengdu University of Traditional Chinese Medicine at 2 sites in China.
Trial summary
The purpose of this study is to determine whether acupuncture is effective for relieving perimenopausal symptoms. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Perimenopause
- What is being tested?
- Acupuncture and Climen 21 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2013to Aug 2015
- Phase
- Phase 2/3
- 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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days.
- Reported relative perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
- Age 40-50 years.
- Not accompanied with conditions that are needed for hormone therapy, e.g., menopause after surgery, active osteoporosis.
- Willing to participate and signing the inform consent.
Who cannot join
- Had a regular menopausal cycle 3 months before this trial.
- Taking estrogen, selective serotonin reuptake inhibitor(SSRI), soy isoflavone, progesterone, Vitamin E or black cohosh in the 4 weeks before inclusion.
- receiving chemoradiotherapy.
- Agnogenic vaginal bleeding.
- Coagulation defeats, or taking anticoagulant drugs, such as warfarin, heparin, etc.
- Dermal diseases, e.g., eczema, psoriasis.
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- Liver or kidney failure.
- Uncontrollable hypertension, diabetes, or thyroid diseases.
- With diabetic neuropathy, malignant cancer and mental diseases (including depression).
- Intend to gestation, in gestation period or lactation period.
- Using sedative or antianxiety drugs.
- With smoking or intemperance problems.
- Using cardiac pacemaker, or joint prosthesis.
- Low compliance.
- Benign tumor in breast.
- Family history of breast cancer.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
First affiliated hospital of Chengdu University of TCM
Chengdu, Sichuan, 610075
About this study
Official title: Acupuncture for Relieving Perimenopausal Symptoms: a Randomised Controlled Trial
The purpose of this study is to determine whether acupuncture is effective for relieving perimenopausal symptoms.
Read the detailed description
- A randomised controlled trial with superiority design
- A total of 220 participants will be included in 3 centers
- 2 arms: acupuncture group and Climen® group
- Conditions
- Perimenopause
- Being tested
- Acupuncture, Climen 21 Tablets
- Keywords
- perimenopause, hot flash, palpitation
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture is a collection of procedures involving penetration of the skin with needles to stimulate certain points on the body. In its classical form it is a characteristic component of traditional Chinese medicine (TCM), a form of alternative medicine, and one of the oldest healing practices in the world.
Climen 21 TabletsDrug
Also called Climen Tablets
Climen Tablets are commonly used for menopausal symptoms
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Using basic points combined with additional points. Basic points are fixed, while additional points will be selected from a list of points categorized by syndrome differentiation. Receives: Other: Acupuncture |
| Climen 21 Tablets | Active comparator | COMPOSITION 11 white tablets each containing estradiol-17-valerate 2 mg, plus 10 pink tablets each containing estradiol-17-valerate 2 mg and cyproterone acetate 1 mg. Receives: Drug: Climen 21 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause Rating Scale
The scale was developed and validated over the years from a research network of many institutions such as Organon Germany, Infratest Munich, Universities of Muenster and Berlin,the Berlin Center for Epidemiology and Health Research, etc. It is a scale consisted of 11 items, ranging from no symptoms to very severe symptoms.
Measured: 12 weeks after randomization
Secondary outcomes (5)
Menopausal Specific Quality of Life Questionnaire
The Menopausal Specific Quality of Life Questionnaire (MENQOL) is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29).
Measured: asessed 0, 6, 12, 24, 36 weeks after randomization
Average hot flash score during 24 hours
Measured: 0, 12, 24, 36 weeks after randomization
Level of Estradiol in serum
Measured: 0, 12, 24 weeks after randomization
Level of follicle stimulating hormone in serum
Measured: 0, 12, 24 weeks after randomization
Level of luteinizing hormone in serum
Measured: 0, 12, 24 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PerimenopauseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu First People's Hospital, Chengdu PLA General Hospital
- Responsible party
- Sponsor
- Investigators
- Ying Li, MD, PhD, Principal investigator, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933204
- Sponsor's protocol ID
- 2012BAI24B01
- Status last verified
- Feb 2020
- First submitted
- 9 Aug 2013
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li Y, Zheng H, Zheng Q, Zhao L, Qin E, Wang Y, Zeng Q, Zheng H, Zhao Y, Sun W, Zhang X, Liu Z, Liu B. Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial. Trials. 2014 May 30;15:198. doi: 10.1186/1745-6215-15-198.
PubMed 24886348
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Relieving Perimenopausal Symptoms: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01933204
- Acronym / sponsor ID
- 2012BAI24B01
- Conditions
- Perimenopause
- Keywords
- perimenopause, hot flash, palpitation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Chengdu First People's Hospital, Chengdu PLA General Hospital
- Study start
- Sep 2013 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Sep 2013 (estimated)
- 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 purpose of this study is to determine whether acupuncture is effective for relieving perimenopausal symptoms.
Detailed description
- A randomised controlled trial with superiority design
- A total of 220 participants will be included in 3 centers
- 2 arms: acupuncture group and Climen® group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureUsing basic points combined with additional points. Basic points are fixed, while additional points will be selected from a list of points categorized by syndrome differentiation. |
| Climen 21 Tablets | Active comparator | Drug: Climen 21 TabletsCOMPOSITION 11 white tablets each containing estradiol-17-valerate 2 mg, plus 10 pink tablets each containing estradiol-17-valerate 2 mg and cyproterone acetate 1 mg. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days.
- Reported relative perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
- Age 40-50 years.
- Not accompanied with conditions that are needed for hormone therapy, e.g., menopause after surgery, active osteoporosis.
- Willing to participate and signing the inform consent.
Key exclusion criteria (16 listed)
- Had a regular menopausal cycle 3 months before this trial.
- Taking estrogen, selective serotonin reuptake inhibitor(SSRI), soy isoflavone, progesterone, Vitamin E or black cohosh in the 4 weeks before inclusion.
- receiving chemoradiotherapy.
- Agnogenic vaginal bleeding.
- Coagulation defeats, or taking anticoagulant drugs, such as warfarin, heparin, etc.
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 |
|---|---|---|
| AcupunctureAcupuncture is a collection of procedures involving penetration of the skin with needles to stimulate certain points on the body. In its classical form it is a characteristic component of traditional Chinese medicine (TCM), a form of alternative medicine, and one of the oldest healing practices in the world. | Other | Acupuncture |
| Climen 21 TabletsAlso: Climen TabletsClimen Tablets are commonly used for menopausal symptoms | Drug | Climen 21 Tablets |
Primary outcome
Menopause Rating Scale
Time frame: 12 weeks after randomization
The scale was developed and validated over the years from a research network of many institutions such as Organon Germany, Infratest Munich, Universities of Muenster and Berlin,the Berlin Center for Epidemiology and Health Research, etc. It is a scale consisted of 11 items, ranging from no symptoms to very severe symptoms.
5 secondary outcomes
Menopausal Specific Quality of Life Questionnaire
Time frame: asessed 0, 6, 12, 24, 36 weeks after randomization
Average hot flash score during 24 hours
Time frame: 0, 12, 24, 36 weeks after randomization
Level of Estradiol in serum
Time frame: 0, 12, 24 weeks after randomization
Level of follicle stimulating hormone in serum
Time frame: 0, 12, 24 weeks after randomization
Level of luteinizing hormone in serum
Time frame: 0, 12, 24 weeks after randomization
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 17 Feb 2020.
- Derived from this study: PubMed 24886348Li Y, Zheng H, Zheng Q, Zhao L, Qin E, Wang Y, Zeng Q, Zheng H, Zhao Y, Sun W, Zhang X, Liu Z, Liu B. Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial. Trials. 2014 May 30;15:198. doi: 10.1186/1745-6215-15-198.
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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.
Ying Li, MD, PhD principal investigator
Chengdu University of Traditional Chinese Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acupuncture and Climen 21 Tablets in people with Perimenopause, run by Chengdu University of Traditional Chinese Medicine at 2 sites in China.
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 16 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause Rating Scale (time frame: 12 weeks after randomization). 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 NCT01933204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.