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Trial Outcomes & Findings for Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion (NCT NCT02726971)

NCT ID: NCT02726971

Last Updated: 2017-04-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

141 participants

Primary outcome timeframe

1 months after the surgery

Results posted on

2017-04-10

Participant Flow

Participant milestones

Participant milestones
Measure
2mg Estradiol Therapy(Low Dose)
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 Estradiol Therapy(High Dose)
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.
Overall Study
STARTED
70
71
Overall Study
COMPLETED
59
62
Overall Study
NOT COMPLETED
11
9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
2mg Estradiol Therapy(Low Dose)
n=59 Participants
mean Age(y):31.9 Gender:Female BMI:21.2 mean Number of miscarriage: 2.3 BMI=body mass index
6mg Estradiol Therapy(High Dose)
n=62 Participants
mean Age(y):32.3 Gender:Female BMI:21.0 mean Number of miscarriage: 2.1 BMI=body mass index
Total
n=121 Participants
Total of all reporting groups
Age, Continuous
31.9 years
STANDARD_DEVIATION 5.0 • n=93 Participants
32.3 years
STANDARD_DEVIATION 4.1 • n=4 Participants
32.3 years
STANDARD_DEVIATION 4.6 • n=27 Participants
Sex: Female, Male
Female
59 Participants
n=93 Participants
62 Participants
n=4 Participants
121 Participants
n=27 Participants
Sex: Female, Male
Male
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Parity
0.2 times
STANDARD_DEVIATION 0.4 • n=93 Participants
0.2 times
STANDARD_DEVIATION 0.4 • n=4 Participants
0.2 times
STANDARD_DEVIATION 0.4 • n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
2mg Estradiol Therapy(Low Dose)
n=59 Participants
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 Estradiol Therapy(High Dose)
n=62 Participants
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.
the AFS Score at Second-look Hysteroscopy
1.6 units on a scale
Standard Deviation 1.4
1.9 units on a scale
Standard Deviation 1.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
2mg Estradiol Therapy(Low Dose)
n=59 Participants
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 Estradiol Therapy(High Dose)
n=62 Participants
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.
the AFS Score at Third-look Hysteroscopy
1.0 units on a scale
Standard Deviation 1.1
1.2 units on a scale
Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
2mg Estradiol Therapy(Low Dose)
n=59 Participants
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 Estradiol Therapy(High Dose)
n=62 Participants
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.
Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy
38 participants
44 participants

Adverse Events

2mg Estradiol Therapy(Low Dose)

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

6mg Estradiol Therapy(High Dose)

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
2mg Estradiol Therapy(Low Dose)
n=59 participants at risk
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 Estradiol Therapy(High Dose)
n=62 participants at risk
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.
Reproductive system and breast disorders
nauseated and bloated
10.2%
6/59 • 2 months after estradiol therapy
16.1%
10/62 • 2 months after estradiol therapy
Hepatobiliary disorders
abnormal liver function
0.00%
0/59 • 2 months after estradiol therapy
1.6%
1/62 • 2 months after estradiol therapy

Additional Information

Dr. YH Liu

Department of Hysteroscopic Center, Fuxing Hospital, Capital Medical University, Beijing, China

Phone: 8618301474064

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place