Contraceptives for Bone Health

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Penn State University

Must not be taking: NSAIDs, Soy products

Disqualifiers: Metabolic, Endocrine, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This preclinical randomized crossover study will examine the effects of oral versus non-oral contraceptive therapy on bone turnover in young exercising women. In an effort to expose the route-dependent effects of oral versus non-oral contraceptive therapy on bone turnover, the investigators will examine 1) the effects of ethinyl estradiol on bone calcium balance using the 41Ca technology and 2) the underlying physiological mechanisms associated with the effects of oral versus non-oral contraceptive therapy on net bone calcium balance.

Research Team

Mary Jane De Souza, PhD

Principal Investigator

Penn State University

Eligibility Criteria

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.

Inclusion Criteria

BMI between 18-29 kg/m2

Non-smoking

Availability to frequently visit the laboratory in the next 12 months

Exclusion Criteria

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

Resistance exercise training (≥ 2 times 30 minutes per week of resistance exercise)

Complete seasonal change of impact mode of physical activity

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral contraceptive pills or a vaginal contraceptive ring for 49 days to assess the effects on bone turnover

7 weeks

Weekly monitoring visits

Follow-up

Participants are monitored for changes in bone turnover markers and 41Ca:Ca ratio after the treatment phase

4 weeks

Treatment Details

Interventions

• Combined Oral Contraceptive (COC)
• Contraceptive Vaginal Ring (CVR)

Trial Overview 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.

Participant Groups

Group I: Contraceptive Vaginal Ring (CVR) Experimental Treatment 1 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 Treatment 1 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.

Combined Oral Contraceptive (COC) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Combined Oral Contraceptives for:

• Contraception
• Menstrual disorders
• Endometriosis
• Polycystic ovary syndrome (PCOS)
• Acne
• Hirsutism

Approved in European Union as Combined Oral Contraceptives for:

• Contraception
• Menstrual disorders
• Endometriosis
• Polycystic ovary syndrome (PCOS)
• Acne
• Hirsutism

Approved in Canada as Combined Oral Contraceptives for:

• Contraception
• Menstrual disorders
• Endometriosis
• Polycystic ovary syndrome (PCOS)
• Acne
• Hirsutism

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Purdue University

Collaborator

Trials

239

Recruited

72,200+