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Premature Ovarian FailurePhase 4FIL-POINCT02783937

Filgrastim for Premature Ovarian Insufficiency

A Phase 4 study testing Filgrastim and Saline in people with Premature Ovarian Failure, run by South Valley University.

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

Filgrastim is a Granulocyte-Colony Stimulating factor (G-CSF). It is an FDA approved drug. Very small embryonic-like stem cells (VSELs) are found in the ovary. Animal studies showed that these cells are able to regenerate the affected ovary. Read more about this study

Who is it for?
Ages 16 to 40 years, women only
Conditions the study is for
Premature Ovarian Failure
What is being tested?
Filgrastim and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
No sites listed yet
Study dates
Nov 2016to Jun 2021
Phase
Phase 4
Are there results?
None posted in the registry

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 16 to 40 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Women with Premature Ovarian Insufficiency (POI): For the purpose of the research women is considered to have POI if she is aged less than 40 years and has amenorrhea of at least 4 month with FSH level above 25 IU/L (repeated twice >4 weeks apart).

Who cannot join

  • Abnormal karyotype
  • Previous pelvic or abdominal radiotherapy
  • Previous surgical removal of the ovarian pathology
  • Chronic disease: renal, liver, cardiac, malignancy

About this study

Official title: Filgrastim for Treatment of Premature Ovarian Insufficiency: Randomized Clinical Trial

Filgrastim is a Granulocyte-Colony Stimulating factor (G-CSF). It is an FDA approved drug. Very small embryonic-like stem cells (VSELs) are found in the ovary. Animal studies showed that these cells are able to regenerate the affected ovary. Studies on mice have shown that Filgrastim result in recovery of oogenesis after chemotherapy-induced gonadal failure (in 2013, 2014, and 2015).

Read the detailed description

Premature ovarian insufficiency (POI) has no curative treatment until now. Filgrastim is an FDA approved Granulocyte-Colony Stimulating factor (G-CSF). Very small embryonic-like stem cells (VSELs) are found in the testis and ovary. VSELs are stem cells that have noticed to survive chemotherapy induced gonadal failure. Data from animal studies showed that stimulation of these stem cells result in generation of the affected gonads. Studies on mice have shown a promising stimulating effect of Filgrastim on recovery of spermatogenesis and oogenesis after chemotherapy-induced gonadal failure (in 2013, 2014, and 2015).

Being tested
Filgrastim, Saline
Keywords
Premature, Ovarian, Failure, Filgrastim
Medical subject headings
Primary Ovarian Insufficiency, Premature Birth

What participants receive

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

  • FilgrastimBiological

    Also called Granulocyte-Colony Stimulating Factor (G-CSF)

    Each case will have two intervention phases done blindly at random with a wash-out period of 6 months:

    Phase A:

    Filgrastim vial (30 million IU/ml) SC injection twice daily for five consecutive days.

    Phase B:

    Injection of saline SC injection twice daily for five consecutive days.

  • SalineDrug

    Also called placebo

    Injection of saline SC injection twice daily for five consecutive days

Study groups in NCT02783937
Study groupRoleWhat they receive
Filgrastim armActive comparatorIntervention: Filgrastim vial (30 million IU/ml) SC injection twice daily for five consecutive days
Receives: Biological: Filgrastim
Placebo armPlacebo comparatorIntervention: Injection of saline SC injection twice daily for five consecutive days.
Receives: Drug: Saline

What is being measured

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

  1. Return of menses

    Return of menses in patients with amenorrhea of at least 4 months

    Measured: 6 months

Secondary outcomes (6)

  1. Pregnancy

    Occurrence of pregnancy as diagnosed by positive serum B-hCG and/or ultrasound

    Measured: 6 months

  2. serum Estradiol

    Normalization of serum Estradiol as tested bi-weekly

    Measured: 6 months

  3. serum Anti-mullarian Hormone (AMH)

    Normalization of serum AMH in patients with AMH level less than 0.9 ng/mL

    Measured: 6 months

  4. serum FSH

    Normalization of serum FSH in patients with FSH level above 25 IU/L

    Measured: 6 months

  5. Follicular growth

    Growth of follicle to size at least 18 mm as monitored by transvaginal ultrasound

    Measured: 6 months

  6. endometrial thickness

    increase of endometrial thickness in women with thin endometrium (less then 8 mm)

    Measured: 6 months

Timeline

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

  1. First posted26 May 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionDec 2020
  4. Study completionJun 2021

Resources

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
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02783937
Sponsor's protocol ID
OBGYN001
Acronym
FIL-POI
Status last verified
Sep 2021
First submitted
17 May 2016
Last updated
21 Sep 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Skaznik-Wikiel ME, McGuire MM, Sukhwani M, Donohue J, Chu T, Krivak TC, Rajkovic A, Orwig KE. Granulocyte colony-stimulating factor with or without stem cell factor extends time to premature ovarian insufficiency in female mice treated with alkylating chemotherapy. Fertil Steril. 2013 Jun;99(7):2045-54.e3. doi: 10.1016/j.fertnstert.2013.01.135. Epub 2013 Feb 26.

    PubMed 23453120

  • Akdemir A, Zeybek B, Akman L, Ergenoglu AM, Yeniel AO, Erbas O, Yavasoglu A, Terek MC, Taskiran D. Granulocyte-colony stimulating factor decreases the extent of ovarian damage caused by cisplatin in an experimental rat model. J Gynecol Oncol. 2014 Oct;25(4):328-33. doi: 10.3802/jgo.2014.25.4.328. Epub 2014 Jun 18.

    PubMed 25142624

  • Benavides-Garcia R, Joachim R, Pina NA, Mutoji KN, Reilly MA, Hermann BP. Granulocyte colony-stimulating factor prevents loss of spermatogenesis after sterilizing busulfan chemotherapy. Fertil Steril. 2015 Jan;103(1):270-80.e8. doi: 10.1016/j.fertnstert.2014.09.023. Epub 2014 Nov 5.

    PubMed 25439845

  • Bhartiya D, Anand S, Parte S. VSELs may obviate cryobanking of gonadal tissue in cancer patients for fertility preservation. J Ovarian Res. 2015 Nov 17;8:75. doi: 10.1186/s13048-015-0199-2.

    PubMed 26576728

  • Roness H, Kalich-Philosoph L, Meirow D. Prevention of chemotherapy-induced ovarian damage: possible roles for hormonal and non-hormonal attenuating agents. Hum Reprod Update. 2014 Sep-Oct;20(5):759-74. doi: 10.1093/humupd/dmu019. Epub 2014 May 15.

    PubMed 24833728

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Filgrastim and Saline in people with Premature Ovarian Failure, run by South Valley University.

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 1 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 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Return of menses (time frame: 6 months). 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 NCT02783937, which also lists 5 linked publications.

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 21 Sep 2021.

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