Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ningbo Women & Children's Hospital | OTHER |
| Jiaxing Maternity and Child Health Care Hospital | OTHER |
| The Affiliated Hospital of Medical School, Ningbo University | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The design was a prospective, randomized, positive-control, parallel-group, multicenter clinical trial. The study included a randomized, parallel-group treatment for 24 weeks in 140 subjects from eight hospitals in seven cities across the country who were diagnosed with Adenomyosis and associated symptoms (dysmenorrhea, with or without heavy menstrual flow) , the subjects were randomly assigned to the following two groups:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mifepristone | Experimental | mifepristone tablets,10mg,One tablet daily, oral treatment |
|
| Triptorelin Acetate | Active Comparator | dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mifepristone | Drug | Mifepristone tablets, 10mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Pain on the Visual Analogue Scale (VAS) at week 24 | The VAS is the most commonly used instrument assessing pain in clinical practice. It reflects the patient's subjective perception of pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). The last observation carry forward was used for missing data. Change=(Week 24 Score - Baseline Score) | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Pictorial blood loss assessment chart(PBAC) | Recording the use of tampons and sanitary towels by placing a tally mark under the day next to the box. Record clots by indicating whether they are the size of a 1p or 50pcoin in the clots/ flooding row under the relevant day. E.g. under day1 you may say 50p*1 and 1p*3. Record any incidences of flooding by placing a tally mark in the clots/ flooding row under the relevant day. A lightly stained towel (pic 1) will score 1 point, a moderately stained towel (pic 2) 5 points, a towel which is saturated with blood(pic 3) will score 20 points. A lightly stained tampon (pic 4) will score 1 point, a moderately stained tampon (pic 5) 5 points and a tampon that is fully saturated will score 10 points. A clot the size of 1p scores 1 point, a 50p sized clot scores 5 pointsand flooding also scores 5 points. Finally, total up the scores. A score of100 or greater may indicate a heavy period. Change=Week 24 Score - Baseline Score |
Not provided
Inclusion criteria.
Exclusion criteria.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinmei Zhang, M.D. | Contact | (+86)18957110072 | zxm20130729@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital of Zhejiang Medical University | Hangzhou | Zhejiang | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| Qilu Hospital of Shandong University |
| OTHER |
| Obstetrics & Gynecology Hospital of Fudan University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Anhui Provincial Hospital | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
| Triptorelin Acetate | Drug | dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks. |
|
| Baseline and week 24 |
| Change from baseline in uterine size at week 24 | Uterine size usually reflects the size of the adenomyosis lesion, and is measured in cubic centimeters. Change=(Week 24 Uterine Size - Baseline Uterine Size)*0.5236 | Baseline and week 24 |
| Change from baseline in hemoglobin at week 24 | Hemoglobin, measured in grams per liter, reflects a patient's level of menstrual blood loss. Change=(Week 24 Hemoglobin Content - Baseline Hemoglobin Content) | Baseline and week 24 |
| Change from baseline in CA125 at week 24 | CA125 is measured in micrograms per liter. Change=(Week 24 Hemoglobin Content - Baseline Hemoglobin Content) | Baseline and week 24 |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011083 |
| Polycyclic Compounds |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |