Menstruation Disturbances
Conditions
Brief summary
Irregular menstrual cycles are common in girls for several years after their first menstrual period. The cause of abnormal menstrual cycles during this time is not well-understood. The purpose of this study is to: 1) monitor girls during a menstrual cycle (with blood and urine sampling and serial pelvic ultrasounds) to identify those girls who do not ovulate (release of an egg from the ovary), and 2) determine whether cycles can be corrected by treating girls with a short course of low-dose estrogen and progesterone.
Interventions
DRUGmicronized progesterone
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* no more than 3 ½ years postmenarchal
Exclusion criteria
* Subjects currently on or previously treated with medications that may affect reproductive hormones (eg birth control pills). * Subjects with severe acne or hirsutism * Subjects who exercise excessively (running \> 20 miles/week or its equivalent) * Subjects with any of the following medical conditions: diabetes, hypertension, hyperlipidemia, valvular heart disease, lupus, rheumatoid arthritis, migraine headaches with aura, undiagnosed breast mass, inflammatory bowel disease, gallbladder disease, sickle cell disease, or thrombophilia. * Current smoker * History of deep venous thrombosis or pulmonary embolism in subject or first-degree relative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovulation in Cycle 2 | 20-40 days | serum progesterone \> 3 ng/ml or presence of corpus luteum on pelvic ultrasound |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interventional estradiol 50 mcg transdermal patch x 7 days oral micronized progesterone 0.5 mg/kg/dose TID x 7 days
micronized progesterone
transdermal estradiol | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Interventional |
|---|---|
| Age, Categorical <=18 years | 6 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 14.9 years STANDARD_DEVIATION 1.5 |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Ovulation in Cycle 2
serum progesterone \> 3 ng/ml or presence of corpus luteum on pelvic ultrasound
Time frame: 20-40 days
Population: subjects with sufficient data in cycle to determine ovulatory/anovulatory status
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interventional | Ovulation in Cycle 2 | ovulatory | 3 Participants |
| Interventional | Ovulation in Cycle 2 | anovulatory | 2 Participants |