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Spironolactone

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Diuretics, Potassium Sparing

16 weeks without medication, then 16 weeks with medication, then 12 months without medication; spironolactone 50 mg tablets: 50-100 mg orally twice daily (1.7-3.3 mg/kg/24 hr)

Spironolactone is an androgen-receptor commonly used (off-label) for hyperandrogenism in girls and women. It is used in this study to determine if androgen blockade can improve ovulation rates in girls with androgen excess, who often have low rates of ovulation in the years following menarche. The spironolactone dose will be as follows: If ≤ 60 kg, 50 mg twice daily; if \> 60 kg, 100 mg twice daily.

Melissa Gilrain, BS

Christine Burt Solorzano, MD

Melissa Gilrain

Adolescent girls with androgen excess have a higher rate of irregular periods and decreased ovulation rates compared to normal girls, and are considered at-risk for developing polycystic ovary syndrome (PCOS). This pilot study will look at whether giving spironolactone might improve ovulation rates in girls with androgen excess, ages 13-19. If this is true, spironolactone treatment to young girls might prevent PCOS from developing and avoid future infertility.

This is a non-randomized, clinical pilot study testing whether 16 weeks of spironolactone improves ovulation rates in post-menarcheal girls with androgen excess. The investigators will recruit girls ages 13-19 with clinical or biochemical androgen excess (defined as hirsutism and/or elevated Tanner stage-specific free testosterone concentrations) who are 4 to 6 years post-menarche. Girls will keep a menstrual diary and collect twice weekly saliva samples for progesterone and estradiol for 16 weeks before and for 16 weeks during spironolactone (if ≤ 60 kg, 50 mg twice daily; if \> 60 kg, 100 mg twice daily \[1.7-3.3 mg/kg/24 hr\]) use. Girls will be asked to continue to collect saliva twice weekly for progesterone and estradiol testing for an additional 16 weeks after discontinuation of spironolactone and to continue menstrual diaries off of study medication for 12 additional months to assess persistence of any spironolactone effect. Ovulation events will be counted per 100 days based on definitive rises in salivary progesterone. The primary outcome will be changes in ovulation rate during spironolactone use compared to baseline. Changes in menstrual regularity via inter-menstrual interval will also be assessed as a secondary outcome of spironolactone administration. Another secondary outcome will be changes in acne and/or hirsutism.

non-randomized cross-sectional, before and after intervention

Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls With Androgen Excess?

Ovulation rate during and after spironolactone compared to before medication. Ovulation will be counted based on salivary progesterone levels. The rate of ovulation will be defined as the number of ovulatory cycles per 100 days of follow-up.

Menstrual length during and after spironolactone compared to before medication. Changes in menstrual regularity will be assessed using inter-menstrual interval (IMI)

Changes in acne before vs. after spironolactone treatment assessed using the Global Acne Grading System

Changes in hirsutism before vs. after spironolactone assessed using a modified Ferriman-Gallwey scoring system

Waterloo Foundation

University of Virginia

Associate Professor of Pediatrics

Pathological Conditions, Anatomical

Neonatal Ovarian Cyst

Patients will choose how they wish to complete the Pubertal Course Questionnaire: electronically (web link), on paper, by telephone, or face-to-face at a follow-up consultation.

Questionnaire

Catherine PIENKOWSKI, MD

This study is based on pubertal surveillance of fetal ovarian cysts (KOF). Fetal ovarian cysts (KOF) detected during fetal ultrasound examinations occur during the 3rd trimester of pregnancy and are of unknown cause.

These cysts are functional in the vast majority of cases and are therefore likely to disappear spontaneously, but they may become complicated before regressing. Apart from complication, the natural evolution of these cysts, which are said to be "simple" because they are liquid on ultrasound, is towards regression in the first months of neo-natal life.

Surveillance during the 1st year of life showed that simple cysts regressed during the 1st trimester. In the case of complicated cysts, oophorectomy was necessary in 9 cases. In the 1-year follow-up, the ovarian recovery rate was significantly different depending on the appearance of the cyst (p\<0.0001); 60 ovaries out of 89 homolateral to the cyst were follicular, of which 48/49 (98%) were carriers of fluid cysts and 12/40 (30%) were initially heterogeneous. The origin of these cysts is unknown, the ovary is again physiologically stimulated during the onset of puberty. No series in the literature gives the long-term ovarian prognosis for these patients. We wish to evaluate the pubertal evolutionary profile of patients followed at the University Hospital for KOF. The data collected concerning puberty (age of menses) will be examined in relation to the age of menses in the siblings and in the mother, as well as to the data in the literature on the age of the first menses in France.

Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst

Age of onset of first menstruation defined with one decimal place (year and month).

Average age of maternal and sister menstruation.

Homo and contralateral ovarian volumes at the cyst.

Presence or not of follicles on both ovaries.

Percentage of girls with clinical signs of hyperandrogenism or elevated testosterone levels.

follicle stimulating hormone (FSH) levels

University Hospital, Toulouse

Prior to the first or second admission (randomly determined), participants will be pretreated for 2 weeks with spironolactone (50 mg twice daily).

Prior to the first or the second admission (randomly determined), participants will be pretreated for 2 weeks with placebo (twice daily).

Spironolactone is an androgen-receptor blocker commonly used (off-label) for hyperandrogenism. The spironolactone dose will be 50 mg taken orally twice daily (for two weeks before admission to the Clinical Research Unit).

Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.

Placebo

Christine M Burt Solorzano, MD

Christopher R McCartney, MD

Su H Kim, MD

The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism (HA), androgen-receptor blockade (spironolactone) alone normalizes sleep-wake luteinizing hormone (LH) pulse frequency (primary endpoint) and overall LH and follicle-stimulating hormone secretion (secondary endpoints).

This is a randomized, placebo-controlled, double-blinded crossover study to test the following hypothesis: In mid- to late pubertal girls with hyperandrogenism, spironolactone (50 mg twice daily) for 2 weeks will reduce sleep-associated luteinizing hormone (LH) pulse frequency compared to placebo treatment. To test this hypothesis, 16 late pubertal girls (signified by either \[a\] post-menarcheal status \[Tanner breast stages 2-5\] or \[b\] Tanner breast stage of 4 or 5 \[whether pre-menarcheal or post-menarcheal\], but no more than 4 years post-menarcheal) with hyperandrogenism (serum \[calculated\] free testosterone concentration greater than the Tanner stage-specific reference range and/or clinical hirsutism) will undergo two clinical research unit (CRU) admissions separated by at least 4 weeks. During each admission, blood will be obtained every 10 minutes through an indwelling IV catheter from 1600 to 0700 h. This will allow full characterization of pulsatile LH secretion in addition to other hormone measurements. Formal polysomnography will be performed during CRU admissions. Subjects will be randomized to be pretreated for 2 weeks with either spironolactone (an androgen receptor blocker commonly used for hyperandrogenism) or placebo prior to the first admission; subjects will be pretreated with the other medication (placebo or spironolactone) for 2 weeks before the second admission in accordance with a cross-over design. The primary endpoint is LH pulse frequency while asleep. (LH pulse frequency while awake is an important secondary endpoint). The sleep-associated LH pulse frequency data from the spironolactone and placebo admissions will be analyzed via a hierarchical linear mixed model (HLMM). Secondary endpoints will include the relationships between sleep stages and LH pulse initiation (analyzed as per Lu et al., Neuroendocrinology 2018 \[Epub ahead of print - doi: 10.1159/000488110\]), and we will test the following hypothesis: In mid- to late pubertal girls with hyperandrogenism, spironolactone will enhance the ability of rapid eye movement (REM) sleep to inhibit LH pulse initiation.

Randomized, placebo-controlled, crossover study

Treatment allocation will be double-blinded. The blind will be broken in the event of any adverse effects that would also lead to study withdrawal. The blind for a given subject will be lifted after the subject completes the study and analysis is complete for that subject.

Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?

Does Spironolactone Normalize Sleep-wake Luteinizing Hormone (LH) Pulse Frequency in Pubertal Girls With Hyperandrogenism? (CBS010)

The sleep-associated (22:00 h - 07:00 h) luteinizing hormone (LH) pulse frequency data from the spironolactone and placebo admissions will be analyzed via a hierarchical linear mixed model (HLMM). Sleep-associated LH pulse frequency will be compared between the spironolactone admission and the placebo admission via a linear contrast of the HLMM least squares LH pulse frequency means.

The wake-associated (16:00 - 22:00) luteinizing hormone (LH) pulse frequency data from the spironolactone and placebo admissions will be analyzed via a hierarchical linear mixed model (HLMM). Wake-associated LH pulse frequency will be compared between the spironolactone admission and the placebo admission via a linear contrast of the HLMM least squares LH pulse frequency means.

We will analyze the proportion of luteinizing hormone (LH) pulses with REM sleep documented in the 5 minutes before each pulse and assess whether this is different between admissions with and without spironolactone. Our hypothesis is that, in the setting of hyperandrogenemia, androgen excess results in more LH pulses associated with REM sleep and that androgen blockade with spironolactone will decrease the number of LH pulses that have REM sleep immediately before the pulse. The determination of sleep stages before LH pulse initiation will be conducted as recently described by our group (Lu et al., Neuroendocrinology 2018 \[Epub ahead of print - doi: 10.1159/000488110\]). The differences in proportion of REM sleep-associated LH pulses between spironolactone and placebo admissions will be analyzed via a hierarchical linear mixed model (HLMM) and compared via a linear contrast of the HLMM least squares LH pulse frequency means.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Assistant Professor in Pediatrics

Hormonal analysis, pelvic US

Nicolas KALFA, MD, PhD

Françoise PARIS, MD, PhD

Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not described to date.

The prenatal diagnosis of ovarian cysts is a common disease with an estimated incidence of 1 case per 2500 births. This pathology is the first diagnosis of abdominal cystic picture on the female fetus in the third trimester of pregnancy.Various complications of ovarian cysts have been described, such as ovarian torsion, breaking the cyst, hemorrhage intra cystic and compression of adjacent viscera. A conservative attitude for uncomplicated cysts is proposed in the literature but surgical care and / or puncture can be made to prevent the occurrence of complications and thus to protect ovarian tissue.However, no data on puberty and long-term ovarian prognosis in this disease is published in the literature. Without this information, no support for the recommendation of a prenatal ovarian cyst can be established formally.

Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst

Serum level of Anti-Mullerian Hormone and ovarian volume at ultrasonography

University Hospital, Montpellier

Micronutrients

Hematinics

Vitamins

Folic Acid

Vitamin B Complex

Folinic Acid

Folate

Vitamin B9

100 pairs of children and their mothers recruited from 2 provinces.

Nancy A. Potischman, Ph.D.

Background:

- Researchers want to collect information on diet, physical activity, and sun exposure in children and young adults. The data can provide information on the effect these factors might have on the development of cancer and other diseases. Information collected only from adults does not accurately measure these factors. To collect more accurate information, both mothers and children will provide information. Study participants will be from Hebei province in northeastern China and Jiangsu province in eastern China.

Objectives:

- To collect and study diet, activity, and sun exposure data from Chinese adolescents and their mothers.

Eligibility:

* Adolescents between 15 and 17 years of age from Hebei and Jiangsu provinces in China.
* Mothers of the study adolescents.

Design:

* Participants will answer questions about their diet, physical activity, and time in the sun.
* Participants will wear a pedometer to measure activity for 7 days. They will also wear a badge to measure sun exposure for 3 days.
* Participants will record their activities and food and drinks consumed for 3 days. Urine samples will be collected for a full day.
* Participants will have a grip strength test. On the last day of the study, they will provide blood, saliva, and toenail samples.
* A smaller separate group of adolescents will provide saliva samples only and complete a food questionnaire.

Background:

Emerging epidemiological evidence suggests that early-life exposures in conjunction with genetic makeup and variability may be important in the etiology of many common adult cancers. Prospectively collected information on adolescent and early adulthood exposures is lacking and current evidence often relies on adult recall of the past with a limited array of exposure variables.

Long Term Objective:

1. To investigate the feasibility of assessing exposures that may be linked to early life exposures and to later diseases. Exposures include diet, physical activity, UV-exposure, DNAmethylation status, body size and reproductive factors. This feasibility work will inform additional research in an existing large Chinese-U.S. CDC collaborative project conducted in 1993 - 1995, the Community Intervention Program (CIP) (n = 247,000).

   Short Term Objectives:
2. To determine the feasibility of collecting and assessing the quality of data on current diet, nutritional status, physical activity, physical strength, UV exposure, DNA methylation status and other environmental exposures as early life determinants of adult cancer in adolescents 15 - 17 years of age and early adulthood in their mothers.
3. To assess differences in methylation status of DNA between those exposed to periconceptional folic acid supplementation and those unexposed.
4. To compare dietary and physical activity self-reporting instruments against objective measures of dietary intake and physical activity, respectively.

Eligibility:

Pairs of mothers and their children aged 15-17 years from the CIP, who completed an associated pilot study in Laoting (Task 1), Hebei provincein the North, and Taicang, Jiangsu provincein the South, and who agree to participate in the study. An additional subsample of 100 children who completed an accompanying study (Task 1), who agree to participate in a sub-study will be eligible.

Design:

This pilot study will include 100 pairs of children and their mothers recruited from 2 provinces. A total of 50 children (aged 16-17years) from a high school (grades 9-10) will be identified in each province. To the extent possible, approximately equal numbers of children aged 16 and 17 years of age will be recruited, stratified by gender and in utero exposure to folic acid. An additional sub-sample of 100 children that completed an accompanying study (Task 1) will be enrolled for only saliva collection and completion of a food frequency questionnaire.

Diet and Nutrition Pilot Study for Chinese Adolescents and Their Mothers

Pilot Study to Test the Methods for the Diet, Nutrition and Physical Activity Feasibility Study of Early Life Determinants of Adult Cancers in a Chinese Cohort of Adolescents and Their Mothers

Participation rates were 66% in the rural community and 87% in the urban community.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls With Androgen Excess?	NCT04075149	Polycystic Ovar... Puberty Disorde... Ovulation Disor...	Spironolactone	13 Years - 19 Years	University of Virginia
Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst	NCT04526392	Fetal Ovarian C...	Questionnaire	8 Years - 18 Years	University Hospital, Toulouse
Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?	NCT04723862	Hyperandrogenis... Polycystic Ovar... Puberty	Spironolactone Placebo	10 Years - 17 Years	University of Virginia
Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?	NCT04723862	Hyperandrogenis... Polycystic Ovar... Puberty	Spironolactone Placebo	10 Years - 17 Years	University of Virginia
Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst	NCT04526392	Fetal Ovarian C...	Questionnaire	8 Years - 18 Years	University Hospital, Toulouse
Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst	NCT02482467	Ovarian Cyst	Hormonal analys...	6 Years - 24 Years	University Hospital, Montpellier
Diet and Nutrition Pilot Study for Chinese Adolescents and Their Mothers	NCT01517139	Methylation Body Compositio... Physical Activi... Puberty		15 Years - 45 Years	National Institutes of Health Clinical Center (CC)
Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst	NCT02482467	Ovarian Cyst	Hormonal analys...	6 Years - 24 Years	University Hospital, Montpellier
Diet and Nutrition Pilot Study for Chinese Adolescents and Their Mothers	NCT01517139	Methylation Body Compositio... Physical Activi... Puberty		15 Years - 45 Years	National Institutes of Health Clinical Center (CC)
Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst	NCT02482467	Ovarian Cyst	Hormonal analys...	6 Years - 24 Years	University Hospital, Montpellier
Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls With Androgen Excess?	NCT04075149	Polycystic Ovar... Puberty Disorde... Ovulation Disor...	Spironolactone	13 Years - 19 Years	University of Virginia

Spots Global Cancer Trial Database for puberty

Every month we try and update this database with for puberty cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for puberty

Every month we try and update this database with for puberty cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for puberty cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.