Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

• Sponsor: Fu Xing Hospital, Capital Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02726971
• Collaborator: (none)
• Enrollment: 141
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 35.2

Study Details

Study Description

Brief Summary

This single-center,prospective,randomized,controlled trial is conducted to evaluate the efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic adhesiolysis in patients with moderate-severe adhesion.

Condition or Disease	Intervention/Treatment	Phase
Asherman Syndrome	Drug: Femoston	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 141 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: A Prospective, Randomized, Controlled Trial Comparing 2 Different Doses of Estrogen Therapy After Hysteroscopic Adhesiolysis as an Adjuvant to Prevent Recurrence of Intrauterine Adhesions
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low dose of oestrogen Patients in this group will build artificial cycle by Femoston.(oral one red tablet daily for 11 days and oral one yellow tablet in the next 10 days). This process will last for 3 months after the surgery. P.S.1.A red tablet contains 2mg estradiol. 2.A yellow tablet contains 2mg estradiol and 10mg dydrogesterone.	Drug: Femoston; Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.
Active Comparator: High dose of oestrogen Patients in this group will build artificial cycle by Femoston.(oral three red tablets daily for 11 days and oral two yellow tablets in the next 10 days). This process will last for 3 months after the surgery. P.S.1.A red tablet contains 2mg estradiol. 2.A yellow tablet contains 2mg estradiol and 10mg dydrogesterone.	Drug: Femoston; Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.

Outcome Measures

Primary Outcome Measures

1. the AFS Score at Second-look Hysteroscopy [1 months after the surgery]

   The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.

Secondary Outcome Measures

1. the AFS Score at Third-look Hysteroscopy [2 months after surgery]

   The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.

2. Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy [3 months after surgery]

   The menstrual pattern is clarified as four types which includes amenorrhea, scant spotting, light period, normal period. The menstrual pattern of every participant was recored and compared with herself (before and 3 months after surgery). The number showed below is patients whose menstrual pattern had improved after surgery and estrogen therapy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Moderate and severe IUA according to the AFS IU adhesion scoring system (AFS 1988 version) (19) showed in Table1 (AFS score≥5);

2. Scheduled for hysteroscopic adhesiolysis;

3. Agreed to have two follow-up hysteroscopy; and

4. Written, informed consent obtained.

Exclusion Criteria:

1. Received estrogen therapy within 3 months of enrollment;

2. Suffering from leiomyoma, polyps, cancer, or polycystic ovarian syndrome (PCOS);

3. History of genital tuberculosis; and

4. Contraindication for estrogen therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fu Xing Hospital,Capital Medical University	Beijing	Beijing	China	100038

Sponsors and Collaborators

• Fu Xing Hospital, Capital Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jun Guo, Chief Physician, Fu Xing Hospital, Capital Medical University
• ClinicalTrials.gov Identifier: NCT02726971
• Other Study ID Numbers: LYuhuan
• First Posted: Apr 4, 2016
• Last Update Posted: Apr 10, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Jun Guo, Chief Physician, Fu Xing Hospital, Capital Medical University: Intrauterine Adhesion; Oestrogen Artificial Periodic Therapy
• Additional relevant MeSH terms: Gynatresia; Tissue Adhesions

Study Results

Participant Flow

Arm/Group Title	2mg Estradiol Therapy(Low Dose)	6mg Estradiol Therapy(High Dose)
Arm/Group Description	2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.	6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.
Period Title: Overall Study
STARTED	70	71
COMPLETED	59	62
NOT COMPLETED	11	9

Baseline Characteristics

Arm/Group Title	2mg Estradiol Therapy(Low Dose)	6mg Estradiol Therapy(High Dose)	Total
Arm/Group Description	mean Age(y):31.9 Gender:Female BMI:21.2 mean Number of miscarriage: 2.3 BMI=body mass index	mean Age(y):32.3 Gender:Female BMI:21.0 mean Number of miscarriage: 2.1 BMI=body mass index	Total of all reporting groups
Overall Participants	59	62	121
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.9 (5.0)	32.3 (4.1)	32.3 (4.6)
Sex: Female, Male (Count of Participants)
Female	59 100%	62 100%	121 100%
Male	0 0%	0 0%	0 0%
Parity (times) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [times]	0.2 (0.4)	0.2 (0.4)	0.2 (0.4)

Outcome Measures

1. Primary Outcome

Title	the AFS Score at Second-look Hysteroscopy
Description	The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.
Time Frame	1 months after the surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	2mg Estradiol Therapy(Low Dose)	6mg Estradiol Therapy(High Dose)
Arm/Group Description	2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.	6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.
Measure Participants	59	62
Median (Standard Deviation) [units on a scale]	1.6 (1.4)	1.9 (1.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	2mg Estradiol Therapy(Low Dose), 6mg Estradiol Therapy(High Dose)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	the AFS Score at Third-look Hysteroscopy
Description	The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.
Time Frame	2 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	2mg Estradiol Therapy(Low Dose)	6mg Estradiol Therapy(High Dose)
Arm/Group Description	2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.	6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.
Measure Participants	59	62
Mean (Standard Deviation) [units on a scale]	1.0 (1.1)	1.2 (1.4)

3. Secondary Outcome

Title	Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy
Description	The menstrual pattern is clarified as four types which includes amenorrhea, scant spotting, light period, normal period. The menstrual pattern of every participant was recored and compared with herself (before and 3 months after surgery). The number showed below is patients whose menstrual pattern had improved after surgery and estrogen therapy.
Time Frame	3 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	2mg Estradiol Therapy(Low Dose)	6mg Estradiol Therapy(High Dose)
Arm/Group Description	2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.	6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.
Measure Participants	59	62
Number [participants]	38 64.4%	44 71%

Adverse Events

Time Frame	2 months after estradiol therapy
Arm/Group Title	2mg Estradiol Therapy(Low Dose)		6mg Estradiol Therapy(High Dose)
Arm/Group Description	2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.		6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.
All Cause Mortality
	2mg Estradiol Therapy(Low Dose)		6mg Estradiol Therapy(High Dose)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	2mg Estradiol Therapy(Low Dose)		6mg Estradiol Therapy(High Dose)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/62 (0%)
Other (Not Including Serious) Adverse Events
	2mg Estradiol Therapy(Low Dose)		6mg Estradiol Therapy(High Dose)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/59 (10.2%)		11/62 (17.7%)
Hepatobiliary disorders
abnormal liver function	0/59 (0%)		1/62 (1.6%)
Reproductive system and breast disorders
nauseated and bloated	6/59 (10.2%)		10/62 (16.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.