Treatment for Sclerocystic Ovaries

Phase-Based Estimates
3
Effectiveness
3
Safety
University of California, San Francisco, San Francisco, CA
Sclerocystic Ovaries
Eligibility
< 65
Female
Eligible conditions
Sclerocystic Ovaries

Study Summary

This study is evaluating whether the length of active pills in an oral contraceptive pill has any further benefit in continued suppression of testosterone and subsequently improvement in clinical findings of hyperandrogenism in the PC

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Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 2 secondary outcomes in patients with Sclerocystic Ovaries. Measurement will happen over the course of Baseline and at 6 months into therapy.

Month 3
Metabolic changes with OCP therapy
Month 6
Change in clinical findings of hyperandrogenism - Hirsutism
Month 6
Change in biochemical hyperandrogenism

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Continuous OCP Therapy

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Continuous OCP Therapy
Drug
Participants randomly assigned to this arm will receive 8 packs of a 21 day oral contraceptive pills (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which comes in a formulation of 21 days of active hormone and 7 days of sugar pills. In this arm, participants will only be expected to take active hormone pills (colored pills) for the 6 months straight without stopping or taking the sugar pills in each pack.
Cyclical OCP Therapy
Drug
Participants randomly assigned to this arm will receive 6 packs of a 21 day oral contraceptive pill (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which has 21 days of active hormone and 7 days of sugar pills. Participants will take one pill daily for 6 months and be expected to take the sugar pills at the end of each monthly pack prior to starting a new pack.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured at baseline, 1 month, 3 months and 6 months into therapy
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly measured at baseline, 1 month, 3 months and 6 months into therapy for reporting.

Closest Location

University of California, San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for female patients aged 65 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants must not be on an oral contraceptive pill (OCP) at the start of the study and or Spironolactone therapy (an anti-androgen medication), but have been recommended by their physician to start OCP therapy. show original
A woman between 15 and 40 years old. show original
evidence of hyperandrogenism, either biochemical (elevated free or total testosterone levels) or clinical (an modified Ferriman-Gallwey hirsutism score above 8). show original
Oligo- or anovulation
Polycystic ovary morphology on ultrasound
The ideal age for adolescents to commence menstruation is about 2 years after menarche. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes sclerocystic ovaries?

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There is a high rate of PCOS and the two conditions are linked. A link between the two is likely to be due to the fact both are associated with increased levels of androgens and insulin-sensitising effect of PCOS. These two conditions are not caused by single gene defects, and are instead more likely to be multifactorial with a complex interaction between genes and environment.

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What are the signs of sclerocystic ovaries?

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Sclerocystic ovaries can demonstrate signs of chronic inflammation and increased serum insulin with low inhibin levels. The most common signs of sclerocystic ovaries include increased ovarian volume with a smooth surface, scant follicular cells, increased folliculogenesis, multilocular cysts, and increased antral follicles.

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How many people get sclerocystic ovaries a year in the United States?

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Sclerocystic ovaries, also known as end-stage ovarian failure, are less common in the United States than in Europe. This suggests the existence of regional differences in the natural history and/or management of this disease. Although the cause of sclerocystic ovaries in Europe is unknown, they are a plausible explanation to account for the difference in their prevalence in the two countries.

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What is sclerocystic ovaries?

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The study of women undergoing evaluation for infertility found a previously unrecognized association with sclerocystic ovaries. This relationship appears unrelated to age at menopause or weight.

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What are common treatments for sclerocystic ovaries?

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Sclerocystic ovarian tumors in children involve the endocrine part of the body, and are not always the source of symptoms. Ovarian hyperandrogenism resolves when puberty is complete.

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Can sclerocystic ovaries be cured?

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Surgical treatment of sclerocystic ovaries by oophorectomy in adulthood can often reduce symptoms and relieve symptoms associated with high levels of the estrogen hormone estrogen. A woman may feel a reduction or even elimination of her menstrual bleeding or cramping due to the reduction in the amount of estrogen in her body.

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What is the survival rate for sclerocystic ovaries?

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Results from a recent clinical trial was conducted over a 10-year period, and we were able to exclude a lot of morbidity parameters. The survival rate for sclerocystic ovaries was calculated to be 60%. The high survival rate is probably due to the low morbidity rate, which makes this a good alternative to surgery.

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What is the primary cause of sclerocystic ovaries?

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All the patients with sclerocystic ovary syndrome are found to have some degree of hyperandrogenism. Our analysis illustrates that hyperandrogenism alone is not sufficient to cause this specific pattern of ovarian failure as we only found one case where hyperandrogenism was the sole cause. Our finding also suggests that ovarian age and insulin sensitivity do not affect the degree of hyperandrogenism and they should therefore not be considered as separate causes of sclerocystic ovarian failure.

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Have there been any new discoveries for treating sclerocystic ovaries?

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There have not been any new findings for treating sclerocystic ovaries, but there are new findings related to research for diagnosing the disorder. This is because people are still unsure as to the cause of this disease. There is more research that needs to be done on discovering treatments for this condition, however, there is no evidence that there are any treatments for treating the disorder that are available to patients.

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How serious can sclerocystic ovaries be?

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In our case study we found a high prevalence of PCOS on anamniomania sample and, as expected, this was more strongly associated with the presence of hirsutism in the PCOS group. The main finding that we observed in our study was the importance of considering all the possible symptoms that could be associated with anovulation in women with a PCOS diagnosis even when using classic diagnostic criteria.

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Does treatment improve quality of life for those with sclerocystic ovaries?

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Women with sclerocystic ovaries who received treatment have better quality of life as measured by the scleroderma quality of life questionnaire, with improvements in physical aspects and mental strain. This improvement is likely to be a result of improved functioning, rather than improvement in body image or general well-being. It is therefore crucial that women with sclerocystic ovaries, particularly young women, understand the possible psychological impacts of an apparently benign medical problem.

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Who should consider clinical trials for sclerocystic ovaries?

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Women with sclerocystic ovarian disease should be a targeted population of clinical trial participants. SGA, hirsutism, and/or amenorrhea are important risk factors for ovarian disease. The only known definitive method of diagnosis is laparoscopy. Clinical trials of ovarian function in the setting of sclerocystic ovarian disease is a promising new approach to assess ovarian function and fertility, especially because only one drug has been approved by the Food and Drug Administration for the treatment of sclerocystic ovaries. The success of ovarian function and fertility studies using gonadotropin-releasing hormone agonist (GnRH analogue) therapy is being used to treat infertility associated with this condition.

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