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Hormone Therapy

Contraceptives for Bone Health

Phase 4

Waitlist Available

Led By Mary Jane De Souza, PhD

Research Sponsored by Penn State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female aged 18-25 years

No apparent metabolic, endocrine, musculoskeletal, or severe psychiatric disease

Must not have

Oral or hormonal contraceptive use in the last 6 months

Current clinical eating disorder or other axis 1 psychiatric disorder or bipolar disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 49 days of contraceptive therapy

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study the effects of birth control pills versus other methods on bone turnover in young women who exercise.

Who is the study for?

This trial is for young women aged 18-25 who are healthy, non-smokers, not currently pregnant or lactating, and have had a regular menstrual cycle. They should be willing to avoid hormonal contraceptives and supplements (except those provided by the study) for about 150 days before starting the trial.

What is being tested?

The study is testing how two types of contraceptives—a pill (COC) and a vaginal ring (CVR)—affect bone health in active women. Using advanced technology, it will compare changes in bone calcium balance between these methods over time.

What are the potential side effects?

While specific side effects aren't listed here, contraceptive methods like COC and CVR can generally cause nausea, weight gain, mood changes, menstrual irregularities, and potentially impact bone density.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 18 and 25.

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I do not have any severe mental health issues or problems with my metabolism, hormones, or bones.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used oral or hormonal contraceptives in the past 6 months.

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I have an eating disorder or another major psychiatric condition.

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I am on medication that interacts with birth control pills or devices.

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I have a diagnosed or suspected hormone-related condition.

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I have a condition that affects how my body absorbs nutrients or affects my bones.

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I regularly use NSAIDs for pain or inflammation.

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I have hyperparathyroidism.

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I have liver or kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 49 days of contraceptive therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~49 days of contraceptive therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 49 days of contraceptive therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in 41Ca:Ca ratio

Secondary study objectives

Changes in serum concentrations of insulin-like growth factor-1 (IGF-1), IGF-binding proteins (IGFBP-1, IGFBP-3), and acid labile subunit (ALS)

Changes in serum concentrations of markers of bone formation and bone resorption

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Contraceptive Vaginal Ring (CVR)Experimental Treatment1 Intervention

We are testing the effects of the vaginal ring (Nuva Ring; 15 µg/d EE, 120 µg/d etonogestrel). When randomized to CVR, participants will insert the contraceptive ring into their vagina . The ring will be worn during weeks 1-3, and again during weeks 5-7. During week 4, no ring will be worn to allow for withdrawal bleeding. If a participant is unable to collect a 24-h urine sample on day 49, they will insert a third ring which will remain in the vagina until she has collected a 24-h urine sample.

Group II: Combined Oral Contraceptive (COC)Experimental Treatment1 Intervention

We are testing the effects of a COC (Apri (Reclipsen); 30 µg EE, 150 µg desogestrel). On the first day of the intervention, the participants randomized to COC will begin taking the pill. One pill will be ingested orally at the same time each day for days 1-49 of the intervention. Pills ingested during days 1-21 and during days 29-49 will be active tablets. Pills ingested on days 22-28 will be tablets without active ingredients. Each participant in the COC group will ingest a pill from the first pack each day for the first 28 days then begin the second pack. If a participant is unable to collect a 24-h urine sample on day 49, she will take active tablets from the third pill pack until she has collected the 24-h urine sample.

0 / 10Eligibility criteria met