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Progestogen

Progesterone for Normal Puberty

Phase 1
Recruiting
Led By Christopher R McCartney, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premenarcheal
Be younger than 18 years old
Must not have
Inability to comprehend what will be done during the study or why it will be done
Basal (follicular) 17-hydroxyprogesterone > 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1100hr to 0700 hr

Summary

This trial is testing whether or not giving progesterone to pubertal girls will prevent the nighttime increase of LH pulses. If successful, this could help researchers understand more about how menstrual cycles are established.

Who is the study for?
This trial is for early to mid-puberty girls who haven't started their periods yet. They should have normal levels of certain hormones and no history of serious heart or lung problems, untreated thyroid issues, abnormally high testosterone or other hormone levels, low blood counts, or significant liver or kidney disease.
What is being tested?
The study tests if small doses of progesterone can prevent an increase in luteinizing hormone (LH) pulses at night in pubertal girls. It also examines whether high testosterone affects progesterone's action on LH pulses. The goal is to understand how menstrual cycles normally start during puberty.
What are the potential side effects?
Progesterone may cause mood swings, headaches, bloating, breast tenderness, and changes in sleep patterns or weight. These side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not started menstruating.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I understand what the study involves and why it's being done.
Select...
My 17-hydroxyprogesterone levels are above 200 ng/ml, and I don't have congenital adrenal hyperplasia.
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I weigh less than 26 kg.
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My thyroid is not functioning properly and I haven't been treated for it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1100hr to 0700 hr
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1100hr to 0700 hr for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Hourly hormone measurements during sampling period.

Side effects data

From 2018 Phase 4 trial • 64 Patients • NCT02255175
18%
Breast Tenderness
15%
Cramps
15%
Itchiness at patch site
12%
Headaches
9%
Nausea
6%
Acne
6%
Lower Back Pain
6%
Hot Flashes
6%
Menstrual Bleeding
6%
Bloating
3%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perimenopausal Women, Depressed
Perimenopausal Women, Non-depressed

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProgesteroneExperimental Treatment1 Intervention
Subjects will take 5-25 mg oral micronized P (based on body weight, to achieve mean plasma P 1-2 ng/ml)
Group II: placeboPlacebo Group1 Intervention
placebo at 1100, 1500, and 1900 h.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Progesterone
2013
Completed Phase 4
~4510

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,662 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,854 Total Patients Enrolled
Christopher R McCartney, MDPrincipal InvestigatorUniversity of Virginia
2 Previous Clinical Trials
162 Total Patients Enrolled

Media Library

Progesterone (Progestogen) Clinical Trial Eligibility Overview. Trial Name: NCT01428089 — Phase 1
Androgen Syndrome Research Study Groups: placebo, Progesterone
Androgen Syndrome Clinical Trial 2023: Progesterone Highlights & Side Effects. Trial Name: NCT01428089 — Phase 1
Progesterone (Progestogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01428089 — Phase 1
~0 spots leftby Dec 2024
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