Asherman SyndromePhase 1/2NCT02726971

Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

A Phase 1/2 study testing Femoston in people with Asherman Syndrome, run by Fu Xing Hospital, Capital Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 25 to 45 years, women only
Conditions the study is for: Asherman Syndrome
What is being tested?: Femoston
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 141 participants
Where: 1 siteChina
Study dates: Apr 2016to Aug 2016
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 25 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Moderate and severe IUA according to the AFS IU adhesion scoring system (AFS 1988 version) (19) showed in Table1 (AFS score≥5);
Scheduled for hysteroscopic adhesiolysis;
Agreed to have two follow-up hysteroscopy; and
Written, informed consent obtained.

Who cannot join

Received estrogen therapy within 3 months of enrollment;
Suffering from leiomyoma, polyps, cancer, or polycystic ovarian syndrome (PCOS);
History of genital tuberculosis; and
Contraindication for estrogen therapy.

Trial locations and contacts

1 site in 1 country.

China1 site

Fu Xing Hospital,Capital Medical University
Beijing, Beijing Municipality, 100038

Other trials in China

About this study

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

Conditions: Asherman Syndrome
Being tested: Femoston
Keywords: Intrauterine Adhesion, Oestrogen Artificial Periodic Therapy
Medical subject headings: Gynatresia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FemostonDrug
Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.

Study groups in NCT02726971
Study group	Role	What they receive
Low dose of oestrogen	Experimental	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. Receives: Drug: Femoston
High dose of oestrogen	Active comparator	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. Receives: Drug: Femoston

What is being measured

The primary outcome is the main question the study is designed to answer.

the AFS Score at Second-look Hysteroscopy
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.
Measured: 1 months after the surgery

Secondary outcomes (2)

the AFS Score at Third-look Hysteroscopy
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.
Measured: 2 months after surgery
Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy
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.
Measured: 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Aug 2016

First posted4 Apr 2016 (estimated)
Study startApr 2016
Primary completionAug 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Asherman SyndromeStudies of the same condition, open and under way.
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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02726971
Sponsor's protocol ID: LYuhuan
Status last verified: Apr 2017
First submitted: 22 Mar 2016
Last updated: 10 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Senescent Endometrial Cells in Patients With Thin Endometrial Lining
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CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)
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RecruitingPhase 1
AD-SVF Therapy for Refractory Endometrial Infertility
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RecruitingEarly Phase 1
Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
Asherman Syndrome, Atrophic Endometrium
Not yet recruitingObservational study
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
Intrauterine Abnormalities in Infertility, Asherman Syndrome

All Asherman Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02726971
Acronym / sponsor ID: LYuhuan
Conditions: Asherman Syndrome
Keywords: Intrauterine Adhesion, Oestrogen Artificial Periodic Therapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 141 participants (actual)
Lead sponsor: Fu Xing Hospital, Capital Medical UniversityUniversity, hospital or other
Study start: Apr 2016
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 4 Apr 2016 (estimated)
Results: Posted 10 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Low dose of oestrogen	Experimental	Drug: FemostonPatients 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.
High dose of oestrogen	Active comparator	Drug: FemostonPatients 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.

Who may qualify

Ages: 25 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Moderate and severe IUA according to the AFS IU adhesion scoring system (AFS 1988 version) (19) showed in Table1 (AFS score≥5);
Scheduled for hysteroscopic adhesiolysis;
Agreed to have two follow-up hysteroscopy; and
Written, informed consent obtained.

Key exclusion criteria (4 listed)

Received estrogen therapy within 3 months of enrollment;
Suffering from leiomyoma, polyps, cancer, or polycystic ovarian syndrome (PCOS);
History of genital tuberculosis; and
Contraindication for estrogen therapy.

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
FemostonFemoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.	Drug	High dose of oestrogen, Low dose of oestrogen

Primary outcome

the AFS Score at Second-look Hysteroscopy
Time frame: 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.

2 secondary outcomes

the AFS Score at Third-look Hysteroscopy
Time frame: 2 months after surgery
Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy
Time frame: 3 months after surgery

Results and safety

Results posted to the registry on 10 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2mg Estradiol Therapy(Low Dose)	70	59
6mg Estradiol Therapy(High Dose)	71	62

Primary outcome: the AFS Score at Second-look Hysteroscopy

Time frame: 1 months after the surgery. Median (Standard Deviation). Unit: units on a scale

Measure	2mg Estradiol Therapy(Low Dose) n = 59	6mg Estradiol Therapy(High Dose) n = 62
Value	1.6 (1.4)	1.9 (1.6)

2mg Estradiol Therapy(Low Dose) vs 6mg Estradiol Therapy(High Dose): p >0.05, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 months after estradiol therapy. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2mg Estradiol Therapy(Low Dose)	0 of 59 (0%)	6 of 59 (10.2%)	Not reported
6mg Estradiol Therapy(High Dose)	0 of 62 (0%)	11 of 62 (17.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Asherman Syndrome

RecruitingObservational study
Senescent Endometrial Cells in Patients With Thin Endometrial Lining
Asherman's Syndrome, Thin Endometrial Lining
Recruiting
CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)
Asherman Syndrome
RecruitingPhase 1
AD-SVF Therapy for Refractory Endometrial Infertility
Endometrium; Atrophy, Intrauterine Synechiae
RecruitingEarly Phase 1
Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
Asherman Syndrome, Atrophic Endometrium
Not yet recruitingObservational study
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
Intrauterine Abnormalities in Infertility, Asherman Syndrome

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Femoston in people with Asherman Syndrome, run by Fu Xing Hospital, Capital Medical University 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 4 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: finished, as of the sponsor's last update on 10 Apr 2017. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the AFS Score at Second-look Hysteroscopy (time frame: 1 months after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02726971.

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 10 Apr 2017.