AzTrials
AzTrials

HealthyPhase 1NCT00377923

Endometrial Effects of Daily Progesterone s.c. 25 and 50 Mg Aqueous Formulation to Female Healthy Volunteers

A Phase 1 study testing Progesterone in people with Healthy, run by IBSA Institut Biochimique SA.

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 is a multiple dose, observer blind, randomised, parallel groups pharmacodynamic and pharmacokinetic study to assess the endometrial effects (predecidual changes) of a new aqueous progesterone formulation administered s.c. at the dose of 25 and 50 mg/day. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Progesterone
How many people
24 participants
Where
No sites listed yet
Study dates
Aug 2005to Mar 2006
Phase
Phase 1
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 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • BMI: 19</=BMI</=25 kg/m2;
  • Proper estrogen priming; absence of progesterone exposure prior to exogenous progesterone administration;
  • normal pelvic ultrasound;
  • absence of active follicular growth following initiation of E2 treatment;
  • Complete suppression of ovarian function;
  • Vital signs: SBP 100-139 mmHg, DBP 50-89, HR 50-90 bpm;
  • Full comprehension of the nature and purpose of the study and possible risks and side effects;
  • signed written informed consent prior to inclusion in the study

Who cannot join

  • pregnant or lactating women;
  • ECG: clinically relevant abnormalities;
  • clinical relevant abnormal physical findings which could interfere with the objectives of the study;
  • clinical relevant abnormal laboratory values indicative of physical illness, ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients;
  • history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
  • history of uterine pathologies (fibroids, polyps, adenomyosis, etc), history of dysfunctional bleeding, relevant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, history of neoplasias (genital apparatus, breast, liver or hormone-dependent cancer) severe liver failure, acute or chronic liver dysfunction, cholestatic jaundice, hypertension, thrombo-phlebitis, thrombo-embolism, cerebro-vascular insult or severe depression; medication, including OTC, during 2 weeks before the start of the study;
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  • participation in the evaluation of any drug within 1 month prior to the start of the study;
  • blood donations during the 1 month prior to this study;
  • history of drug, alcohol [>1 drink/day defined according to USDA Dietary Guidelines 2005 (18)] caffeine (>5 cups/ day of coffee or tea) or tobacco abuse (≥10 cigarettes/day);
  • Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits within the past 4 weeks.

About this study

This is a multiple dose, observer blind, randomised, parallel groups pharmacodynamic and pharmacokinetic study to assess the endometrial effects (predecidual changes) of a new aqueous progesterone formulation administered s.c. at the dose of 25 and 50 mg/day.

Read the detailed description

This study is designed in order to assess the efficacy of the investigational product (Progesterone acqueous s.c. formulation) when it is administered at the dose of 25 and 50 mg. The induced predecidual changes will be evaluated through endometrial bioptic samplings, performed on day 11 and will be compared between the two treatment groups.

The pharmacokinetic evaluation was designed according to internationally recognised guidelines for PK studies.

Conditions
Healthy
Being tested
Progesterone
Keywords
pharmacodynamic and pharmacokinetic study, Progesterone, healthy volunteers, Endometrial decidualisation

What participants receive

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

  • ProgesteroneDrug

What is being measured

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

  1. partial and full predecidual changes in endometrial samples on the 11th day of exposure to the IMP compared to the findings on the 11th day after ovulation in the menstrual cycle, according to Noyes criteria

Secondary outcomes (1)

  1. PK profile of progesterone at the steady-state following the 25 or 50 mg/day of progesterone s.c. at the time of endometrial biopsy, local tolerability

Timeline

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

  1. First posted19 Sep 2006 (estimated)
  2. Study startAug 2005
  3. Study completionMar 2006

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
24 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00377923
Sponsor's protocol ID
05A/Prg05
Status last verified
Sep 2006
First submitted
18 Sep 2006
Last updated
20 Sep 2006
Results posted
No

Publications

  • de Ziegler D, Bouchard P. Understanding endometrial physiology and menstrual disorders in the 1990s. Curr Opin Obstet Gynecol. 1993 Jun;5(3):378-88.

    PubMed 8329654

  • de Ziegler D, Bergeron C, Cornel C, Medalie DA, Massai MR, Milgrom E, Frydman R, Bouchard P. Effects of luteal estradiol on the secretory transformation of human endometrium and plasma gonadotropins. J Clin Endocrinol Metab. 1992 Feb;74(2):322-31. doi: 10.1210/jcem.74.2.1730810.

    PubMed 1730810

  • NOYES RW, HAMAN JO. Accuracy of endometrial dating; correlation of endometrial dating with basal body temperature and menses. Fertil Steril. 1953 Nov-Dec;4(6):504-17. doi: 10.1016/s0015-0282(16)31446-7. No abstract available.

    PubMed 13107761

  • Noyes RW, Hertig AT, Rock J. Dating the endometrial biopsy. Am J Obstet Gynecol. 1975 May;122(2):262-3. doi: 10.1016/s0002-9378(16)33500-1. No abstract available.

    PubMed 1155504

  • Soliman S, Daya S, Collins J, Hughes EG. The role of luteal phase support in infertility treatment: a meta-analysis of randomized trials. Fertil Steril. 1994 Jun;61(6):1068-76. doi: 10.1016/s0015-0282(16)56758-2.

    PubMed 8194619

  • Pritts EA, Atwood AK. Luteal phase support in infertility treatment: a meta-analysis of the randomized trials. Hum Reprod. 2002 Sep;17(9):2287-99. doi: 10.1093/humrep/17.9.2287.

    PubMed 12202415

  • Bourgain C, Smitz J, Devroey P. Meta-analysis on luteal phase support. Hum Reprod. 2003 Mar;18(3):656; author reply 656-7. doi: 10.1093/humrep/deg098. No abstract available.

    PubMed 12615845

  • Daya S, Gunby J. Luteal phase support in assisted reproduction cycles. Cochrane Database Syst Rev. 2004;(3):CD004830. doi: 10.1002/14651858.CD004830.

    PubMed 15266541

  • de Ziegler D, Cornel C, Bergeron C, Hazout A, Bouchard P, Frydman R. Controlled preparation of the endometrium with exogenous estradiol and progesterone in women having functioning ovaries. Fertil Steril. 1991 Nov;56(5):851-5. doi: 10.1016/s0015-0282(16)54654-8.

    PubMed 1936317

  • Lelaidier C, de Ziegler D, Gaetano J, Hazout A, Fernandez H, Frydman R. Controlled preparation of the endometrium with exogenous oestradiol and progesterone: a novel regimen not using a gonadotrophin-releasing hormone agonist. Hum Reprod. 1992 Nov;7(10):1353-6. doi: 10.1093/oxfordjournals.humrep.a137572.

    PubMed 1291558

  • Fanchin R, De Ziegler D, Bergeron C, Righini C, Torrisi C, Frydman R. Transvaginal administration of progesterone. Obstet Gynecol. 1997 Sep;90(3):396-401. doi: 10.1016/s0029-7844(97)00270-6.

    PubMed 9277651

  • Gibbons WE, Toner JP, Hamacher P, Kolm P. Experience with a novel vaginal progesterone preparation in a donor oocyte program. Fertil Steril. 1998 Jan;69(1):96-101. doi: 10.1016/s0015-0282(97)00457-3.

    PubMed 9457941

  • Jobanputra K, Toner JP, Denoncourt R, Gibbons WE. Crinone 8% (90 mg) given once daily for progesterone replacement therapy in donor egg cycles. Fertil Steril. 1999 Dec;72(6):980-4. doi: 10.1016/s0015-0282(99)00390-8.

    PubMed 10593367

  • Damario MA, Barmat L, Liu HC, Davis OK, Rosenwaks Z. Dual suppression with oral contraceptives and gonadotrophin releasing-hormone agonists improves in-vitro fertilization outcome in high responder patients. Hum Reprod. 1997 Nov;12(11):2359-65. doi: 10.1093/humrep/12.11.2359.

    PubMed 9436663

  • de Ziegler D, Fanchin R. Progesterone and progestins: applications in gynecology. Steroids. 2000 Oct-Nov;65(10-11):671-9. doi: 10.1016/s0039-128x(00)00123-9.

    PubMed 11108875

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Progesterone in people with Healthy, run by IBSA Institut Biochimique SA.

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 8 inclusion and 10 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 20 Sep 2006. 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. 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 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.

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?

partial and full predecidual changes in endometrial samples on the 11th day of exposure to the IMP compared to the findings on the 11th day after ovulation in the menstrual cycle, according to Noyes criteria. 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 NCT00377923, which also lists 16 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 20 Sep 2006.

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