Dexamethasone + rhCG for Polycystic Ovary Syndrome

(CBS001 Trial)

Overseen By Christine Burt Solorzano, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Virginia

Must be taking: Iron supplements

Disqualifiers: Diabetes, Pregnancy, Genetic syndromes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss your specific situation with the study team.

What evidence supports the effectiveness of the drug combination of Dexamethasone and rhCG for treating Polycystic Ovary Syndrome?

Research shows that combining dexamethasone with human chorionic gonadotropin (hCG) can help women with polycystic ovary syndrome (PCOS) who haven't responded to other treatments to ovulate and conceive. In one study, 81% of women ovulated and 74% conceived using a similar combination, suggesting this drug combination could be effective. ^{1 2 3 4 5}

Is the combination of Dexamethasone and rhCG safe for use in humans?

The combination of Dexamethasone and human chorionic gonadotropin (hCG) has been used safely in women with polycystic ovary syndrome, with only one case of moderate ovarian hyperstimulation reported. Recombinant human chorionic gonadotropin (rhCG) has also been found to be safe and well-tolerated in healthy men and women. ^{1 2 6 7 8}

How does the drug Dexamethasone + rhCG differ from other treatments for Polycystic Ovary Syndrome?

The combination of Dexamethasone and recombinant human chorionic gonadotropin (rhCG) is unique because it combines a steroid (Dexamethasone) with a hormone (rhCG) to enhance ovulation in women with Polycystic Ovary Syndrome who have not responded to other treatments. This approach may reduce the required dose of other hormones and improve ovulation and pregnancy rates compared to using hormones alone. ^{1 2 3 7 9}

What is the purpose of this trial?

Women with polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body hair, irregular menstrual periods, or no menstrual periods excess body weight, and infertility. It also results in elevated androgen levels such as testosterone. In women with PCOS, the majority of excess androgens are produced by the ovaries. However, it is unknown whether the ovaries are fully active during early puberty. The purpose of this study is to determine how the ovaries contribute to the production of male hormones in the body during different stages of puberty, so that it can be better understood why some females have excess androgens.

Research Team

Christine M Burt Solorzano, MD

Principal Investigator

University of Virginia Center for Research in Reproduction

Eligibility Criteria

This trial is for girls aged 7-18 who may have signs of excess male hormones, like facial hair or irregular periods. They should be normal weight or overweight but not obese and must have normal lab results except for minor variations due to obesity. Girls with certain health conditions or on other research protocols are excluded.

Inclusion Criteria

My blood tests are mostly normal, though I may have slight changes due to being overweight.

My BMI is within the normal or overweight range for my age.

I am a girl aged between 7 and 18.

Exclusion Criteria

I have diabetes or my blood sugar/A1c levels are high.

I understand what the study involves and why it's being done.

I have a history of congenital adrenal hyperplasia or my 17-hydroxyprogesterone levels are above 300 ng/dL.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dexamethasone and rhCG (Ovidrel) to assess ovarian contribution to androgen production

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dexamethasone
• rhCG

Trial Overview The study investigates how the ovaries contribute to producing male hormones in adolescent girls at different puberty stages, using medications Dexamethasone and rhCG. This could help understand why some females develop high levels of these hormones.

Participant Groups

Group I: dexamethasone, rhCG (Ovidrel) Experimental Treatment 2 Interventions

rhCG (Ovidrel) administered 25 mcg IV; dexamethasone administered 1 mg PO

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Findings from Research

The novel recombinant human chorionic gonadotropin (rhCG; CG beta) was found to be safe and well-tolerated in a first-in-human trial involving 84 healthy subjects, indicating its potential for further clinical development.

CG beta demonstrated higher pharmacokinetic (PK) exposure compared to CG alfa, with a longer half-life and greater serum testosterone response, suggesting that it may be effective at lower therapeutic doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human trial assessing the pharmacokinetic-pharmacodynamic profile of a novel recombinant human chorionic gonadotropin in healthy women and men of reproductive age. Broksø Kyhl, LE., Hesse, C., Larsson, P., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Induction of ovulation with combined human gonadotropins and dexamethasone in women with polycystic ovarian disease. [2019]

2. Ireland pubmed.ncbi.nlm.nih.gov

Induction of ovulation by combined clomiphene citrate and dexamethasone treatment in clomiphene citrate nonresponders. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Clomiphene and dexamethasone in women unresponsive to clomiphene alone. [2013]

4. Germany pubmed.ncbi.nlm.nih.gov

[Dexamethasone does not normalize disordered LH pulsatility in hyperandrogenemic ovarian insufficiency]. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical findings and hormonal responses in patients with polycystic ovarian disease with normal versus elevated LH levels. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

First-in-human trial assessing the pharmacokinetic-pharmacodynamic profile of a novel recombinant human chorionic gonadotropin in healthy women and men of reproductive age. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Age-matched comparison of recombinant and urinary HCG for final follicular maturation. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial comparing highly purified (HP-hCG) and recombinant hCG (r-hCG) for triggering ovulation in ART. [2012]

9. England pubmed.ncbi.nlm.nih.gov

Induction of final follicular maturation and early luteinization in women undergoing ovulation induction for assisted reproduction treatment--recombinant HCG versus urinary HCG. The European Recombinant Human Chorionic Gonadotrophin Study Group. [2022]