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CompletedNCT00714233Updated May 15, 2015Results posted

Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

A Phase 3 interventional study of Metformin and Oral Contraceptive Pills (Yasmin) in Polycystic Ovary Syndrome, sponsored by University of Rochester. Completed. Open to female participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-15.

Sponsored by University of Rochester · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
Female
01

Study summary

A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to:

  1. reduce fasting glucose levels
  2. reduce androgen hormone levels
  3. improve sex steroid binding, and
  4. improve lipids (fatty substances in the blood)
Read the detailed description

Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern.

Many adolescents with PCOS have increased levels of insulin, a hormone that controls the body's sugar balance. These increased insulin levels may play a role in the development of polycystic ovary syndrome. There are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. Metformin is one of these drugs. Metformin is a drug currently used in the management of diabetes to control blood sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished.

02

Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Polycystic Ovary Syndrome
  • Overweight Adolescent Girls
  • Irregular Menstrual Cycles
03

In context

Polycystic Ovary Syndrome

975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.

This study's enrollment of 43 is below the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

University of Rochester is the lead sponsor of 728 studies on the registry; 115 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Browse University of Rochester studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Menstrual irregularity defined as cycle length > 45 days
  • Overweight as BMI > 25
  • Clinical evidence of hirsuitism or acne
  • Testosterone > 50ng/dL

Exclusion criteria

Exclusion Criteria:

  • History of diabetes mellitus
  • History of Cushing's disease
  • History of hyperprolactinemia
  • Untreated hypo or hyperthyroidism
  • History of adrenal hyperplasia
  • Significant renal impairment
  • Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study
  • Exercise > 10 hours per week
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    1

    Metformin

    Drug: Metformin

  • Experimental
    2

    Oral Contraceptive Pills

    Drug: Oral Contraceptive Pills (Yasmin)

  • Active comparator
    3

    lifestyle modification program

    Behavioral: Lifestyle Modification

  • Placebo comparator
    4

    placebo to active metformin arm

    Drug: placebo

Interventions

  • DrugMetformin

    Metformin 425mg. capsules, 2 capsules BID x 24 weeks

  • DrugOral Contraceptive Pills (Yasmin)

    Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks

    Also known as: Yasmin oral COntraceptive tabs

  • BehavioralLifestyle Modification

    weekly classes x 24 weeks for training in diet, exercise and behavior modification skills

  • Drugplacebo

    placebo to the active metformin arm. 2 capsules BID x 24 weeks.

    Also known as: pharmacy matched placebo capsules

06

What researchers measure

Primary outcomes

  1. Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification

    The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY

    Time frame: 24 week

Secondary outcomes

  1. Weight Loss in Lifestyle Intervention Group

    In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI

    Time frame: baseline and 24 weeks

  2. Change in Free Androgen Index (FAI)

    Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI \<4 is consistent with a normal range.

    Time frame: baseline and 24 weeks

  3. Change in SHBG

    Measurement of SHBG by treatment group pre and post intervention

    Time frame: baseline and 24 weeks

  4. Triglyceride Concentration by Treatment Group

    Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo

    Time frame: baseline and 24 weeks

  5. Change in Fasting Glucose

    Change in fasting glucose concentration by treatment group pre to post intervention

    Time frame: baseline and 24 weeks

07

Results

Posted Sep 16, 2011

Participant flow

Participant flow — Overall Study
MilestoneMetforminOral ContraceptiveLifestyle CounselingPlacebo to Metformin
Started10111110
Completed610106
Not completed4114

Outcome measures

PrimaryMeasure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification

The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY

Time frame:
24 week
Reported as:
Number · participants
Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification
participantsMetforminOral ContraceptiveLifestyle CounselingPlacebo to Metformin
Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification10111110
SecondaryWeight Loss in Lifestyle Intervention Group

In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI

Time frame:
baseline and 24 weeks
Reported as:
Mean · kg/m^2
Weight Loss in Lifestyle Intervention Group
kg/m^2Lifestyle Program
Weight Loss in Lifestyle Intervention Group-1.1 ± 6.6
Statistical analysis
  • Lifestyle Program · t-test, 2 sided · p = <0.05
SecondaryChange in Free Androgen Index (FAI)

Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI \<4 is consistent with a normal range.

Time frame:
baseline and 24 weeks
Reported as:
Mean · total T/SHBG
Change in Free Androgen Index (FAI)
total T/SHBGMetforminOral ContraceptiveLifestlePlacebo to Metformin
Change in Free Androgen Index (FAI)-0.1 ± 3.2-16.7 ± 8-13.7 ± 10.91.2 ± 12.3
SecondaryChange in SHBG

Measurement of SHBG by treatment group pre and post intervention

Time frame:
baseline and 24 weeks
Reported as:
Mean · ratio
Change in SHBG
ratioMetforminOral ContraceptiveLifestyle CounselingPlacebo to Metformin
Change in SHBG2.6 ± 8.677 ± 38.417.6 ± 18.32 ± 8.4
SecondaryTriglyceride Concentration by Treatment Group

Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo

Time frame:
baseline and 24 weeks
Reported as:
Mean · mg/dL
Triglyceride Concentration by Treatment Group
mg/dLMetforminOral ContraceptiveLifestyle CounselingPlacebo to Metformin
Triglyceride Concentration by Treatment Group-22.3 ± 24.14.6 ± 412.2 ± 36.4-6.6 ± 27.8
SecondaryChange in Fasting Glucose

Change in fasting glucose concentration by treatment group pre to post intervention

Time frame:
baseline and 24 weeks
Reported as:
Mean · mg/dL
Change in Fasting Glucose
mg/dLMetforminOral ContraceptiveLifestyle CounselingPlacebo to Metformin
Change in Fasting Glucose-6.7 ± 10.36.9 ± 8.70.4 ± 7.2-1.1 ± 7.2

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Metformin—0/10 (0%)0/10 (0%)
Oral Contraceptive—0/11 (0%)0/11 (0%)
Lifestyle Counseling—0/11 (0%)0/11 (0%)
Placebo to Metformin—0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)MetforminOral ContraceptiveLifestyle CounselingPlacebo to MetforminTotal
<=18 years1011111042
Between 18 and 65 years00000
>=65 years00000
Age, Continuous
Age, Continuous(years)MetforminOral ContraceptiveLifestyle CounselingPlacebo to MetforminTotal
Mean16 ± 1.715.4 ± 1.415.4 ± 1.215.4 ± 1.715.6 ± 1.4
Sex: Female, Male
Sex: Female, Male(Participants)MetforminOral ContraceptiveLifestyle CounselingPlacebo to MetforminTotal
Female1011111042
Male00000
Region of Enrollment
Region of Enrollment(participants)MetforminOral ContraceptiveLifestyle CounselingPlacebo to MetforminTotal
United States1011111042
08

Study locations

No study locations are listed for this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2002, a primary completion of Apr 2004 and a completion of Dec 2007. It does not say whether these dates are actual or estimated.

Results were first posted in Sep 2011, 7 years 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2008
First posted
Jul 14, 2008
Start
Aug 2002
Primary completionActual
Apr 2004
CompletionActual
Dec 2007
Results first posted
Sep 16, 2011
Last update
May 15, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00714233
Lead sponsor
University of Rochester
Responsible party
Kathleen M. Hoeger, MD (Professor, University of Rochester) — Principal investigator
First posted
Jul 14, 2008
Start date
Aug 2002
Primary completion
Apr 2004
Completion
Dec 2007
Results posted
Sep 16, 2011
Last update
May 15, 2015

Study contacts

Kathleen M Hoeger, MD
principal investigator · University of Rochester

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Metformin · Drospirenone and ethinyl estradiol combination

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