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New treatment option for Functional Hypothalamic Amenorrhea
Official title The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
ClinicalTrials.gov ID: NCT07580950
What this study is testing
What is traditional Chinese medicine?
traditional Chinese medicine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for functional hypothalamic amenorrhea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to validate the efficacy and safety of the "two-step cycle-regulating approach integrating Chinese and Western medicine: rapid restoration of menstruation with Western medicine, and nourish the kidney and soothe the liver, nourishing the essence, and reinforcing the vital essence and strengthening the primordial qi with Chinese medicine" through a nationwide randomized controlled clinical trial involving 210 cases. Guided by traditional Chinese medicine theory, the study will explore the mechanism of integrated Chinese and Western medicine in the treatment of functional hypothalamic amenorrhea through gut microbiota and metabolomics research.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 40, women only
You may be able to join if
- Diagnostic criteria for functional hypothalamic amenorrhea
- primary or secondary amenorrhea
- Normal or low FSH levels, LH \< 5 IU/L, E2 \< 50 pg/mL
- Exclusion of amenorrhea caused by: -Organic lesions of the hypothalamus or pituitary gland , Ovarian amenorrhea , Uterine or lower genital tract...
You likely can't join if
- Individuals who have used relevant medications within the past 3 months
- History of substance abuse or dependence (alcohol or drugs) within the past 3 months; heavy smokers (those consuming 20 or more cigarettes daily)
- Individuals with severe or unstable physical illnesses, including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, respiratory...
- Lactating or pregnant women, or females within one year postpartum
- History of allergy to the investigational drug; contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston
- Individuals with or suspected of having estrogen-sensitive tumors (e.g., endometrial cancer, breast cancer).
See the full eligibility criteria
- Diagnostic criteria for functional hypothalamic amenorrhea
- primary or secondary amenorrhea
- Normal or low FSH levels, LH \< 5 IU/L, E2 \< 50 pg/mL
- Exclusion of amenorrhea caused by: -Organic lesions of the hypothalamus or pituitary gland , Ovarian amenorrhea , Uterine or lower genital tract developmental abnormalities ,Drug-induced amenorrhea ,Other causes of...
- Individuals who have used relevant medications within the past 3 months
- History of substance abuse or dependence (alcohol or drugs) within the past 3 months; heavy smokers (those consuming 20 or more cigarettes daily)
- Individuals with severe or unstable physical illnesses, including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, respiratory, endocrine, neurological, immune, or hematological disorders; psychiatric...
- Lactating or pregnant women, or females within one year postpartum
- History of allergy to the investigational drug; contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston
- Individuals with or suspected of having estrogen-sensitive tumors (e.g., endometrial cancer, breast cancer).
- History of thromboembolic disease or thrombotic tendency.
- Participation in another investigational drug clinical trial within 1 month prior to inclusion in this study (first interview).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 14 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.