PCOSNCT05872425
Efficacy and Safety of Dingkundan Combined With Combination Oral Contraceptives in the Treatment of PCOS
A study testing DingKunDan(GuangYuYuan) and Drospirenone and Ethinylestradiol Tablets (Ⅱ) in people with PCOS, run by Guangdong Women and Children Hospital at 1 site in China.
Trial summary
This is a single-center, non-randomized, open-label clinical study to investigate the efficacy and safety of Dingkundan (DKP) combined with compound oral contraceptives (COC) in the treatment of PCOS. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- DingKunDan(GuangYuYuan) and Drospirenone and Ethinylestradiol Tablets (Ⅱ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Apr 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with PCOS.
- Aged from 18 to 35 years old, in the reproductive age.
- Have not taken any hormone or Chinese medicine in the past 3 months.
Who cannot join
- Age < 18 years or > 35 years.
- Have taken hormones or Chinese medicine in the last 3 months.
- Have congenital adrenal hyperplasia, Cushing's syndrome, or androgen-secreting tumors.
- Abnormal function of liver and kidney.
- Have hrombotic disease, arterial or venous thromboembolism, or major organic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Dingkundan Combined With Combination Oral Contraceptives in the Treatment of PCOS: an Open-label, Non-randomized Controlled Clinical Study
This is a single-center, non-randomized, open-label clinical study to investigate the efficacy and safety of Dingkundan (DKP) combined with compound oral contraceptives (COC) in the treatment of PCOS. This study is mainly to compare the effect of COC plus DKP verse COC on reducing androgen, improving the function of ovarian and the individual metabolism. The secondary objective of our study is to explore the efficacy of DKP on pregnancy in patients with PCOS and its safety.
Read the detailed description
In this study, the decreased level of serum androgen was used as the main outcome index. It was assumed that PCOS patients treated with Dingkundan combined with compound oral contraceptives for 3 menstrual cycles had decreased serum androgen by 0.53nmol/L. It was assumed that the serum androgen decreased by 0.21nmol/L after 3 menstrual cycles of combined oral contraceptives alone. If α = 0.05, the test degree was 80%, and the dropout rate of 20%, considering that the sample size ratio between the experimental group and control group was 1, the sample size of experimental group and control group were 60 cases each, and 120 cases in total. All the samples were recruited from the Department of Gynecology and Women's Health Care of Guangdong Women and Children's Health Hospital.
This study was approved by the Ethics Committee of the hospital, and all participants are required to sign informed consent.
Before the study, researchers should be trained in a unified and standardized manner, including medication methods, observation indicators, judgment and treatment of adverse reactions/events, and reporting of serious adverse events.
The researcher must adequately and accurately record the research process so that the research data can be verified. These records can be divided into two categories: study documents and raw patient data. Study documents include protocols and amendments, sample informed consent forms, researcher resumes and authorization forms, and other required documents and correspondence. Original documents of patients' include patient inpatient/outpatient records, doctor's and nurse's orders, appointment dates, original laboratory reports, ultrasound, signed informed consent forms, patient screening forms, etc.
During the study period, if the subject withdraws the informed consent, or refuses the further follow-up, or loses follow-up, or dies, the sample will be disqualified.
If the subject withdraws consent, refuses to continue the study, or the investigator determines that the subject's clinical symptoms/physical condition has worsened and that the subject is no longer suitable for the study, or the subject develops toxicity intolerance, such as any clinical AE, laboratory abnormalitiesor, or the investigator determines that the subject has reached the study endpoint, or any circumstances warrant discontinuation of this study judged by the investigator, or the study sponsor discontinues the study, this study will be stop.
Anyway, this clinical study is conducted in accordance with the Declaration of Helsinki and relevant regulations on clinical trials in China. It can only be carried out after obtaining the approval of the Ethics Committee. The modification of clinical research protocols, informed documents and other materials involved in clinical research should be approved by the Ethics Committee before implementation. The investigator should protect the rights and privacy of the subject.
- Conditions
- PCOS
- Being tested
- DingKunDan(GuangYuYuan), Drospirenone and Ethinylestradiol Tablets (Ⅱ)
- Keywords
- Dingkundan(DKP), Compound Oral Contraceptives(COC), PCOS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DingKunDan(GuangYuYuan)Drug
Also called DingKunDan(GuangYuYuan): Z20059003, Drospirenone and Ethinylestradiol Tablets (Ⅱ): H20140972
The experimental group would be given DingKunDan, the subjects should take 3.5g each time, twice a day.
Subjects in the control group only needed to take COC. Both groups take medicine for 3 months consecutively as a course of treatment.
Drospirenone and Ethinylestradiol Tablets (Ⅱ)Drug
Also called Drospirenone and Ethinylestradiol Tablets (Ⅱ): H20140972
The experimental group and the control group would be given oral Drospirenone and Ethinylestradiol Tablets (Ⅱ). According to the packaging instructions, on the first day of menstruation, according to the packaging instructions, the subjects should take the tablet, then take the rest sequential at the same time every day for 28 consecutive days, menstruation would happen after drug withdrawal (or after 7 days of drug withdrawal), and the next medication cycle begin on the first day of menstruation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with DingKunDan(GuangYuYuan) combined with compound oral contraceptives | Experimental | This arm is treated with DingKunDan plus compound oral contraceptives: Drospirenone and Ethinylestradiol Tablets (Ⅱ). Receives: Drug: DingKunDan(GuangYuYuan); Drug: Drospirenone and Ethinylestradiol Tablets (Ⅱ) |
| Treatment with compound oral contraceptives | Active comparator | This arm is only treated with compound oral contraceptives: Drospirenone and Ethinylestradiol Tablets (Ⅱ). Receives: Drug: DingKunDan(GuangYuYuan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum androgen
Basic serum androgen is one of the primary outcome measure and is aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.
Measured: Before inclusion；after one treatment course.
Free testosterone
Free testosterones is one of the primary outcome measureis aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.
Measured: Before inclusion；after one treatment course.
Androstenedione
Androstenedione is one of the primary outcome measure is aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.
Measured: Before inclusion；after one treatment course.
sex hormone-binding globulin（SHBG）
SHBG is one of the primary outcome measure is aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.
Measured: Before inclusion；after one treatment course.
Secondary outcomes (5)
Fasting blood-glucose (FBG)
This outcome measure is aim to assess if Dingkundan is a useful adjuvant therapy for PCOS in improving metabolism.
Measured: Before inclusion；after one treatment course.
Fasting insulin (FINS)
This outcome measure is aim to assess if Dingkundan is a useful adjuvant therapy for PCOS in improving metabolism.
Measured: Before inclusion；after one treatment course.
HOMA-IR
HOMA-IR is used to assess the level of insulin resistance and help to evaluate the metabolism of individuals.
Measured: Before inclusion；after one treatment course.
Anti-Müllerian hormone (AMH)
AMH is an important index to evaluate AMH is an important index to evaluate the reserve function of ovarian.
Measured: Before inclusion；after one treatment course.
HCY
HCY is used to assess the level of folate metabolism
Measured: Before inclusion；after one treatment course.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Feb 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872425
- Sponsor's protocol ID
- GuangdongWCH-LiLi
- Status last verified
- May 2024
- First submitted
- 27 Apr 2023
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dingkundan Combined With Combination Oral Contraceptives in the Treatment of PCOS: an Open-label, Non-randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05872425
- Acronym / sponsor ID
- GuangdongWCH-LiLi
- Conditions
- PCOS
- Keywords
- Dingkundan(DKP), Compound Oral Contraceptives(COC), PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 24 May 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 single-center, non-randomized, open-label clinical study to investigate the efficacy and safety of Dingkundan (DKP) combined with compound oral contraceptives (COC) in the treatment of PCOS. This study is mainly to compare the effect of COC plus DKP verse COC on reducing androgen, improving the function of ovarian and the individual metabolism. The secondary objective of our study is to explore the efficacy of DKP on pregnancy in patients with PCOS and its safety.
Detailed description
In this study, the decreased level of serum androgen was used as the main outcome index. It was assumed that PCOS patients treated with Dingkundan combined with compound oral contraceptives for 3 menstrual cycles had decreased serum androgen by 0.53nmol/L. It was assumed that the serum androgen decreased by 0.21nmol/L after 3 menstrual cycles of combined oral contraceptives alone. If α = 0.05, the test degree was 80%, and the dropout rate of 20%, considering that the sample size ratio between the experimental group and control group was 1, the sample size of experimental group and control group were 60 cases each, and 120 cases in total. All the samples were recruited from the Department of Gynecology and Women's Health Care of Guangdong Women and Children's Health Hospital.
This study was approved by the Ethics Committee of the hospital, and all participants are required to sign informed consent.
Before the study, researchers should be trained in a unified and standardized manner, including medication methods, observation indicators, judgment and treatment of adverse reactions/events, and reporting of serious adverse events.
The researcher must adequately and accurately record the research process so that the research data can be verified. These records can be divided into two categories: study documents and raw patient data. Study documents include protocols and amendments, sample informed consent forms, researcher resumes and authorization forms, and other required documents and correspondence. Original documents of patients' include patient inpatient/outpatient records, doctor's and nurse's orders, appointment dates, original laboratory reports, ultrasound, signed informed consent forms, patient screening forms, etc.
During the study period, if the subject withdraws the informed consent, or refuses the further follow-up, or loses follow-up, or dies, the sample will be disqualified.
If the subject withdraws consent, refuses to continue the study, or the investigator determines that the subject's clinical symptoms/physical condition has worsened and that the subject is no longer suitable for the study, or the subject develops toxicity intolerance, such as any clinical AE, laboratory abnormalitiesor, or the investigator determines that the subject has reached the study endpoint, or any circumstances warrant discontinuation of this study judged by the investigator, or the study sponsor discontinues the study, this study will be stop.
Anyway, this clinical study is conducted in accordance with the Declaration of Helsinki and relevant regulations on clinical trials in China. It can only be carried out after obtaining the approval of the Ethics Committee. The modification of clinical research protocols, informed documents and other materials involved in clinical research should be approved by the Ethics Committee before implementation. The investigator should protect the rights and privacy of the subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with DingKunDan(GuangYuYuan) combined with compound oral contraceptives | Experimental | Drug: DingKunDan(GuangYuYuan), Drug: Drospirenone and Ethinylestradiol Tablets (Ⅱ)This arm is treated with DingKunDan plus compound oral contraceptives: Drospirenone and Ethinylestradiol Tablets (Ⅱ). |
| Treatment with compound oral contraceptives | Active comparator | Drug: DingKunDan(GuangYuYuan)This arm is only treated with compound oral contraceptives: Drospirenone and Ethinylestradiol Tablets (Ⅱ). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women diagnosed with PCOS.
- Aged from 18 to 35 years old, in the reproductive age.
- Have not taken any hormone or Chinese medicine in the past 3 months.
Key exclusion criteria (5 listed)
- Age < 18 years or > 35 years.
- Have taken hormones or Chinese medicine in the last 3 months.
- Have congenital adrenal hyperplasia, Cushing's syndrome, or androgen-secreting tumors.
- Abnormal function of liver and kidney.
- Have hrombotic disease, arterial or venous thromboembolism, or major organic disease.
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 |
|---|---|---|
| DingKunDan(GuangYuYuan)Also: DingKunDan(GuangYuYuan): Z20059003, Drospirenone and Ethinylestradiol Tablets (Ⅱ): H20140972The experimental group would be given DingKunDan, the subjects should take 3.5g each time, twice a day. Subjects in the control group only needed to take COC. Both groups take medicine for 3 months consecutively as a course of treatment. | Drug | Treatment with DingKunDan(GuangYuYuan) combined with compound oral contraceptives, Treatment with compound oral contraceptives |
| Drospirenone and Ethinylestradiol Tablets (Ⅱ)Also: Drospirenone and Ethinylestradiol Tablets (Ⅱ): H20140972The experimental group and the control group would be given oral Drospirenone and Ethinylestradiol Tablets (Ⅱ). According to the packaging instructions, on the first day of menstruation, according to the packaging instructions, the subjects should take the tablet, then take the rest sequential at the same time every day for 28 consecutive days, menstruation would happen after drug withdrawal (or after 7 days of drug withdrawal), and the next medication cycle begin on the first day of menstruation. | Drug | Treatment with DingKunDan(GuangYuYuan) combined with compound oral contraceptives |
Primary outcome
Serum androgen
Time frame: Before inclusion；after one treatment course.
Basic serum androgen is one of the primary outcome measure and is aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.
Free testosterone
Time frame: Before inclusion；after one treatment course.
Free testosterones is one of the primary outcome measureis aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.
Androstenedione
Time frame: Before inclusion；after one treatment course.
Androstenedione is one of the primary outcome measure is aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.
sex hormone-binding globulin（SHBG）
Time frame: Before inclusion；after one treatment course.
SHBG is one of the primary outcome measure is aim to evaluate the efficacy of Dingkundan that as an adjuvant therapy for PCOS.
5 secondary outcomes
Fasting blood-glucose (FBG)
Time frame: Before inclusion；after one treatment course.
Fasting insulin (FINS)
Time frame: Before inclusion；after one treatment course.
HOMA-IR
Time frame: Before inclusion；after one treatment course.
Anti-Müllerian hormone (AMH)
Time frame: Before inclusion；after one treatment course.
HCY
Time frame: Before inclusion；after one treatment course.
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 30 May 2024.
- Individual participant dataSharing planned: Undecided
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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 DingKunDan(GuangYuYuan) and Drospirenone and Ethinylestradiol Tablets (Ⅱ) in people with PCOS, run by Guangdong Women and Children Hospital at 1 site 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 3 inclusion and 5 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 30 May 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 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.
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?
Serum androgen (time frame: Before inclusion；after one treatment course.). 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 30 May 2024.