NCT03264638

Brief Summary

This study evaluates the effects and biological mechanisms of Dingkundan，Diane-35 and the combination of Dingkundan and Diane-35 in the treatment of polycystic syndrome(PCOS) in adults women. One third of participants will receive Dingkundan capsules, one third of participants will receive Diane-35 Pills, and the another third will receive Dingkundan capsules and Diane-35 in combination.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
315

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

August 13, 2017

Last Update Submit

February 2, 2018

Conditions

PCOS

Keywords

PCOSDingkundanDiane-35

Outcome Measures

Primary Outcomes (2)

  • symptoms

    PCOS symptoms

    5 minutes

  • sex hormone levels changes

    sex hormone levels changes

    5 minutes

Secondary Outcomes (5)

  • lipid metabolism

    5 minutes

  • metabolites figure spectrum

    5 minutes

  • Fasting insulin

    5 minutes

  • glycosylated hemoglobin

    5 minutes

  • fasting blood glucose

    5 minutes

Study Arms (3)

Dingkundan

EXPERIMENTAL

Dingkundan 7g capsule by mouth, twice daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles

Drug: Dingkundan

Dingkundan & Diane-35

EXPERIMENTAL

Dingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles

Drug: Dingkundan & Diane-35

Diane-35

ACTIVE COMPARATOR

Diane-35 one pill by mouth,once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles

Drug: Diane-35

Interventions

DingkundanDRUG

Dingkundan 7g capsule by mouth, twice daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles

Also known as: A
Dingkundan
Dingkundan & Diane-35DRUG

Dingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles

Also known as: A&B
Dingkundan & Diane-35
Diane-35DRUG

Diane-35 one pill by mouth,once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles

Also known as: B
Diane-35

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is a female between the age of 18 and 40.
  • Subject diagnosed as PCOS by the 2003 Rotterdam criteria.
  • Subject provides written informed consent.

You may not qualify if:

  • Subject has other endocrine diseases,such as adrenal hyperplasias or tumor, androgen-secreting tumours, Cushing's syndrome,thyroid diseases and hyperprolactinemia.
  • Subject has received related medical or surgical treatment in the past 3 months.
  • Subject suffered from substance abuse or dependence(such as alcohol or drugs);
  • Subject is a heavy smoker(reaching or more than 20 cigarettes a day).
  • Subject is pregnant or lactating or within 1 year after delivery.
  • Subject has a severe systemic disease, such as cardiovascular system
  • Subject has a history of malignancy or radiotherapy.
  • Subject has an allergic history to the drugs used in the study.
  • Subject has mental disorder incapable of elementary cooperations.
  • Subject has participated in other clinical researches of medicine within 3 month prior to randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, China/Beiing, 100000, China

RECRUITING

Related Publications (5)

  • Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.

    PMID: 14688154BACKGROUND

  • Amiri M, Ramezani Tehrani F, Nahidi F, Kabir A, Azizi F, Carmina E. Effects of oral contraceptives on metabolic profile in women with polycystic ovary syndrome: A meta-analysis comparing products containing cyproterone acetate with third generation progestins. Metabolism. 2017 Aug;73:22-35. doi: 10.1016/j.metabol.2017.05.001. Epub 2017 May 10.

    PMID: 28732568BACKGROUND

  • Ding X, Deng Y, Wang Y, Xue W, Zhu S, Ma X, Ma R, Sun A. Serum metabolomic profiling reveals potential biomarkers in assessing the management of women with polycystic ovary syndrome: a randomized controlled trial. Chin Med J (Engl). 2022 Jan 5;135(1):79-85. doi: 10.1097/CM9.0000000000001705.

    PMID: 34873082DERIVED

  • Deng Y, Wang YF, Zhu SY, Ma X, Xue W, Ma RL, Sun AJ. Is There An Advantage of Using Dingkun Pill () alone or in Combination with Diane-35 for Management of Polycystic Ovary Syndrome? A Randomized Controlled Trial. Chin J Integr Med. 2020 Dec;26(12):883-889. doi: 10.1007/s11655-020-3097-4. Epub 2020 Sep 11.

    PMID: 32915426DERIVED

  • Deng Y, Xue W, Wang YF, Liu XH, Zhu SY, Ma X, Zuo HL, Jiang JF, Zheng TP, Sun AJ. Insulin Resistance in Polycystic Ovary Syndrome Improved by Chinese Medicine Dingkun Pill (): A Randomized Controlled Clinical Trial. Chin J Integr Med. 2019 Apr;25(4):246-251. doi: 10.1007/s11655-018-2947-1. Epub 2019 Jun 25.

    PMID: 31236888DERIVED

Related Links

MeSH Terms

Interventions

Cyproterone acetate, ethinyl estradiol drug combination

Study Officials

  • Aijun Sun, MD

    Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, MD

CONTACT

139-1198-8831lileigh@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One third of participanta will receive Dingkun Dan Pills, one third of participanta will receive Diane-35 Pills, and the another third will receive Dingkun Dan pills and Diane-35 in combination.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 13, 2017

First Posted

August 29, 2017

Study Start

October 1, 2016

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

February 5, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Network platform, and the website will be attached later.

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
Within 2 months after the trial complete
Access Criteria
Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement

Locations

CN(1)