Functional Hypothalamic AmenorrheaPhase 4NCT07580950
The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
A Phase 4 study testing traditional Chinese medicine and Western medicine in people with Functional Hypothalamic Amenorrhea, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 40 years, women only
- Conditions the study is for
- Functional Hypothalamic Amenorrhea
- What is being tested?
- traditional Chinese medicine and Western medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2025to 30 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 14 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 amenorrhea
Who cannot join
- 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 patients
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Yan Deng, Doctor, 01069158331, yanndeng@163.com
Aijun Sun, Doctor
About this study
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.
- Conditions
- Functional Hypothalamic Amenorrhea
- Being tested
- traditional Chinese medicine, Western medicine
- Keywords
- Functional Hypothalamic Amenorrhea, Integrated Traditional Chinese and Western Clinical Medicine, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional Chinese medicineDrug
traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
Western medicineDrug
Western medicine（Femoston 2/10)
| Study group | Role | What they receive |
|---|---|---|
| Femoston group | Active comparator | Femoston 2/10 (estradiol 2mg / dydrogesterone 10mg), 1 tablet daily. Receives: Drug: Western medicine |
| Ba Zhen Yi Mu Pill and Ding Kun Dan group | Experimental | Participants received Traditional Chinese medicine Ba Zhen Yi Mu Pill (6g three times daily) and Ding Kun Dan (7g twice daily) concurrently. Receives: Drug: traditional Chinese medicine |
| Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston group | Experimental | Participants in the intervention group received Ba Zhen Yi Mu Pill (6 g twice daily), Ding Kun Dan (7g twice daily), and Femoston (estradiol 2mg / dydrogesterone 10mg, 1 tablet daily) concurrently. Receives: Drug: traditional Chinese medicine; Drug: Western medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual patterns during treatment and after discontinuation
Document the number of episodes of menstruation during the treatment and follow-up period
Measured: From enrollment, during the treatment of 6 months, and within 3 months after treatment
Sex hormone levels
Measure the levels of sex hormones in the blood, including Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Progesterone (P), Prolactin (PRL), Dehydroepiandrosterone Sulfate (DHEA-S), and Anti-Müllerian Hormone (AMH).
Measured: from enrollment to the end of treatment at 6 months
Uterine volume
Uterine volume was calculated using the length, width, and anteroposterior diameter measured by ultrasound, according to the formula Volume = 0.5233 × L × W × AP, where L, W, and AP represent the length, width, and anteroposterior diameter of the uterus measured by ultrasound.
Measured: From enrollment to the end of treatment at 6 months
Quality of Life Score(36-Item Short Form Health Survey，SF 36)
The SF-36 (36-Item Short Form Health Survey) score ranges from 0 to 100, where higher scores represent better quality of life outcomes.
Measured: From enrollment to the end of treatment at 6 months
Total ovarian volume
Total ovarian volume (cm³) was calculated by summing the volumes of the left and right ovaries, each of which was derived using the ellipsoid formula: V = 0.523 × length × width × thickness .The three perpendicular diameters of the ovary (length, width, and thickness) were measured using ultrasound.
Measured: from enrollment to the end of treatment at 6 months
Secondary outcomes (4)
Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)
Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II). Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms (worse outcome).
Measured: From enrollment to 3 months after the end of treatment
Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale.
Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms (worse outcome).
Measured: From enrollment to 3 months after the end of treatment
Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10)
Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). Total scores range from 0 to 40, with higher scores indicating greater perceived stress (worse outcome).
Measured: From enrollment to 3 months after the end of treatment
Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26)
Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26) . Total scores range from 0 to 78 , with higher scores indicating more disordered eating pathology (worse outcome) . A score of 20 or higher is considered indicative of an elevated risk for an eating disorder, warranting further clinical evaluation
Measured: From enrollment to 3 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start22 Oct 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Hypothalamic AmenorrheaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Dongfang Hospital Beijing University of Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Shenyang Maternal and Child Health Hospital, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing University of Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580950
- Sponsor's protocol ID
- 2025YFC3508004
- Other IDs
- 2025YFC3508004
- Status last verified
- Oct 2025
- First submitted
- 27 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
- ClinicalTrials.gov ID
- NCT07580950
- Acronym / sponsor ID
- 2025YFC3508004
- Conditions
- Functional Hypothalamic Amenorrhea
- Keywords
- Functional Hypothalamic Amenorrhea, Integrated Traditional Chinese and Western Clinical Medicine, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Dongfang Hospital Beijing University of Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Shenyang Maternal and Child Health Hospital, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing University of Chinese Medicine
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 12 May 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Femoston group | Active comparator | Drug: Western medicineFemoston 2/10 (estradiol 2mg / dydrogesterone 10mg), 1 tablet daily. |
| Ba Zhen Yi Mu Pill and Ding Kun Dan group | Experimental | Drug: traditional Chinese medicineParticipants received Traditional Chinese medicine Ba Zhen Yi Mu Pill (6g three times daily) and Ding Kun Dan (7g twice daily) concurrently. |
| Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston group | Experimental | Drug: traditional Chinese medicine, Drug: Western medicineParticipants in the intervention group received Ba Zhen Yi Mu Pill (6 g twice daily), Ding Kun Dan (7g twice daily), and Femoston (estradiol 2mg / dydrogesterone 10mg, 1 tablet daily) concurrently. |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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 amenorrhea
Key exclusion criteria (8 listed)
- 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 patients
- 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
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 |
|---|---|---|
| traditional Chinese medicinetraditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan） | Drug | Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston group, Ba Zhen Yi Mu Pill and Ding Kun Dan group |
| Western medicineWestern medicine（Femoston 2/10) | Drug | Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston group, Femoston group |
Primary outcome
Menstrual patterns during treatment and after discontinuation
Time frame: From enrollment, during the treatment of 6 months, and within 3 months after treatment
Document the number of episodes of menstruation during the treatment and follow-up period
Sex hormone levels
Time frame: from enrollment to the end of treatment at 6 months
Measure the levels of sex hormones in the blood, including Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Progesterone (P), Prolactin (PRL), Dehydroepiandrosterone Sulfate (DHEA-S), and Anti-Müllerian Hormone (AMH).
Uterine volume
Time frame: From enrollment to the end of treatment at 6 months
Uterine volume was calculated using the length, width, and anteroposterior diameter measured by ultrasound, according to the formula Volume = 0.5233 × L × W × AP, where L, W, and AP represent the length, width, and anteroposterior diameter of the uterus measured by ultrasound.
Quality of Life Score(36-Item Short Form Health Survey，SF 36)
Time frame: From enrollment to the end of treatment at 6 months
The SF-36 (36-Item Short Form Health Survey) score ranges from 0 to 100, where higher scores represent better quality of life outcomes.
Total ovarian volume
Time frame: from enrollment to the end of treatment at 6 months
Total ovarian volume (cm³) was calculated by summing the volumes of the left and right ovaries, each of which was derived using the ellipsoid formula: V = 0.523 × length × width × thickness .The three perpendicular diameters of the ovary (length, width, and thickness) were measured using ultrasound.
4 secondary outcomes
Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)
Time frame: From enrollment to 3 months after the end of treatment
Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale.
Time frame: From enrollment to 3 months after the end of treatment
Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10)
Time frame: From enrollment to 3 months after the end of treatment
Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26)
Time frame: From enrollment to 3 months after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
Related trials for Functional Hypothalamic Amenorrhea
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
RecruitingPhase 2
Role of Estrogen on Skeletal Outcomes in FHA
Bone Strength, Bone Density
Active, not recruitingObservational study
Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)
Hypothalamic Amenorrhea
Not yet recruiting
Effects of Resistance Training on Women With Functional Hypothalamic Amenorrhea
Amenorrhea, Functional Hypothalamic Amenorrhea (FHA)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing traditional Chinese medicine and Western medicine in people with Functional Hypothalamic Amenorrhea, run by Peking Union Medical College 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 12 May 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Deng, Doctor (86+010-69158331, yanndeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual patterns during treatment and after discontinuation (time frame: From enrollment, during the treatment of 6 months, and within 3 months after treatment). The study lists 5 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 12 May 2026.