CLINICAL TRIALS PROFILE FOR NORPLANT SYSTEM IN PLASTIC CONTAINER

All Clinical Trials for Norplant System In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00064766 ↗	Norplant and Irregular Bleeding/Spotting	Unknown status	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4	2003-02-01	Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients using progestin-only hormonal contraception such as levonorgestrel implants (Norplant). Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease, may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using Norplant.
NCT00445887 ↗	Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2008-03-10	This randomized phase II trial is studying how well levonorgestrel works in preventing ovarian cancer in patients at high risk for ovarian cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of levonorgestrel may prevent ovarian cancer.
NCT00445887 ↗	Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer	Completed	Gynecologic Oncology Group	Phase 2	2008-03-10	This randomized phase II trial is studying how well levonorgestrel works in preventing ovarian cancer in patients at high risk for ovarian cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of levonorgestrel may prevent ovarian cancer.
NCT00563576 ↗	Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation	Completed	Columbia University	N/A	2007-09-01	Many women choose Depo-Provera for birth control because it is easy to use and very effective. However, a significant number of Depo-Provera users experience irregular bleeding during the first 90 days. Many users discontinue after their first injection due to irregular bleeding. This study will evaluate the effect of using an estrogen vaginal ring during the first 90 days of Depo-Provera use to see if it is acceptable to women and whether it decreases irregular bleeding during the first 90 days of use and increases continuation to a second injection.
NCT00710606 ↗	Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®	Completed	Organon	N/A	2008-06-01	There are over 60 million women of reproductive age in the U.S. and a majority of these women qualify as overweight or obese. Evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. Studies with the combined hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®) demonstrate higher failure rates in heavier versus lighter women. Weight related differences in the effectiveness of NuvaRing® need further study. A single secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no difference in pregnancy rates among women in the highest weight decile (>166#) versus the rest of the study population using the ring. (Westhoff, 2005) The finding of no difference, however, was influenced by too few obese subjects in the analysis which contributed to wide confidence limits. Additional studies are needed to explore how well the contraceptive ring functions to maintain effective serum steroid concentrations to suppress ovarian activity in obese women. This investigation focused on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study was a prospective clinical trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those with a BMI 30-39.9. We recruited forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers included sonographic evidence of follicular development and ovulation as well as circulating E2 levels which strongly correlate with follicular development and endometrial proliferation during the second month of NuvaRing® use. Assessment of these parameters will translated to understanding contraceptive-mediated suppression of ovarian function in these two groups. Subjects also logged patterns of ring use and bleeding patterns during the study period.
NCT00710606 ↗	Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®	Completed	Columbia University	N/A	2008-06-01	There are over 60 million women of reproductive age in the U.S. and a majority of these women qualify as overweight or obese. Evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. Studies with the combined hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®) demonstrate higher failure rates in heavier versus lighter women. Weight related differences in the effectiveness of NuvaRing® need further study. A single secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no difference in pregnancy rates among women in the highest weight decile (>166#) versus the rest of the study population using the ring. (Westhoff, 2005) The finding of no difference, however, was influenced by too few obese subjects in the analysis which contributed to wide confidence limits. Additional studies are needed to explore how well the contraceptive ring functions to maintain effective serum steroid concentrations to suppress ovarian activity in obese women. This investigation focused on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study was a prospective clinical trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those with a BMI 30-39.9. We recruited forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers included sonographic evidence of follicular development and ovulation as well as circulating E2 levels which strongly correlate with follicular development and endometrial proliferation during the second month of NuvaRing® use. Assessment of these parameters will translated to understanding contraceptive-mediated suppression of ovarian function in these two groups. Subjects also logged patterns of ring use and bleeding patterns during the study period.
NCT00789802 ↗	A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC	Completed	American College of Obstetricians and Gynecologists	N/A	2008-11-01	We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo. The objective of this study is to compare the total number of days of bleeding experienced by first time users of the LNG-IUC randomized to oral naproxen or estradiol patch compared to those randomized to placebo for the first 12 weeks of use. We will enroll women initiating LNG-IUC to one of 3 groups, transdermal estrogen, oral naproxen or oral placebo. We will enroll a total of 114 women, 38 in each group. Women will keep bleeding diaries for 16 weeks which will be used to calculate the total number of bleeding or spotting days. Statistical analysis will be performed to evaluate if there is less bleeding among the treatment arms then the placebo arm.

Clinical Trial Conditions for Norplant System In Plastic Container

Condition Name

Condition Name for Norplant System In Plastic Container
Intervention	Trials
Contraception	1
Endometrial Bleeding	1
Genital Diseases, Female	1
Menstruation Disturbances	1

Condition MeSH

Condition MeSH for Norplant System In Plastic Container
Intervention	Trials
Hemorrhage	3
Menstruation Disturbances	1
Metrorrhagia	1
Ovarian Neoplasms	1

Clinical Trial Locations for Norplant System In Plastic Container

Trials by Country

Trials by Country for Norplant System In Plastic Container
Location	Trials
United States	27

Trials by US State

Trials by US State for Norplant System In Plastic Container
Location	Trials
New York	3
Missouri	2
Virginia	2
Rhode Island	1
Oregon	1

Clinical Trial Progress for Norplant System In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Norplant System In Plastic Container
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1
N/A	4

Clinical Trial Status

Clinical Trial Status for Norplant System In Plastic Container
Clinical Trial Phase	Trials
Completed	6
Unknown status	1

Clinical Trial Sponsors for Norplant System In Plastic Container

Sponsor Name

Sponsor Name for Norplant System In Plastic Container
Sponsor	Trials
Columbia University	2
Organon	1
American College of Obstetricians and Gynecologists	1

Sponsor Type

Sponsor Type for Norplant System In Plastic Container
Sponsor	Trials
Other	8
NIH	2
Industry	1

Clinical Trials and Efficacy of the Norplant System

Introduction to Norplant System

The Norplant System, which utilizes levonorgestrel implants, has been a subject of interest for both female and male contraception. Here, we will focus on its use in male contraception and the clinical trials associated with it.

Clinical Trials for Male Contraception

Recent studies have explored the use of levonorgestrel implants, such as Norplant II, in combination with androgens for male contraception. These trials aimed to assess the efficacy of these combinations in suppressing spermatogenesis.

Study Design and Participants

In a clinical trial published in the Journal of Clinical Endocrinology & Metabolism, 39 healthy male volunteers aged 20-45 years were randomly assigned to two groups. Group 1 received two transdermal testosterone (T) patches daily, while Group 2 received combined Norplant II (delivering approximately 160 μg/day levonorgestrel) plus T patches[1][4].

Later, the study was expanded to include two more groups: Group 3 received oral levonorgestrel (125 μg/day) plus T patches, and Group 4 received Norplant II plus testosterone enanthate (TE) injections (100 mg/week)[1][4].

Efficacy and Outcomes

The results showed that the combination of Norplant II and T patches was not very effective, with suppression of spermatogenesis to severe oligozoospermia occurring in less than 60% of subjects. However, when the transdermal T delivery system was substituted with TE injections (Group 4), the suppression of spermatogenesis was significantly improved. All subjects in the Norplant II plus TE group had persistent sperm concentrations less than 3 × 10^6/ml from week 12 until the end of treatment[1][4].

Key Findings

• Suppression of Spermatogenesis: The combination of Norplant II and TE injections was highly effective, achieving azoospermia in 93% of the subjects in this group.
• Hormonal Changes: Serum FSH and LH levels were most decreased in the Norplant II plus TE group, indicating effective suppression of spermatogenesis.
• Safety Profile: There were no significant changes in weight, hematocrit, clinical chemistry, or prostate-specific antigen levels in any of the treatment groups, except for a suppression of serum high-density lipoprotein cholesterol[1][4].

Market Analysis and Projections for Plastic Containers

While the Norplant System itself is not directly related to the market for plastic containers, understanding the broader context of medical device packaging can provide insights into the potential market dynamics.

Global Plastic Containers Market

The global plastic containers market is projected to grow significantly over the next decade. Here are some key points:

• Market Size and Growth: The global plastic containers market is expected to grow from $218.04 billion in 2024 to $344.79 billion by 2032, at a CAGR of 5.9%[5].
• Key Players: Companies like ALPLA, Alpha Packaging, Amcor, Plastipak Packaging, and Consolidated Container Company are major players in this market. ALPLA's diversified product portfolio and innovations are significant factors in its leading position[5].

Rotomolded Containers Market

Rotomolded containers, which could be relevant for packaging medical devices like the Norplant System, are also experiencing growth:

• Market Growth: The global rotomolded containers market is expected to reach USD 6.3 billion by 2034, growing at a CAGR of 3.4% during the forecast period. Polyethylene-based rotomolded containers are set to dominate the market, accounting for over 60% of sales in 2024[2].
• Drivers: The market is driven by the durability, weather resistance, cost-effectiveness, and customization flexibility of rotomolded containers. The increasing demand for sustainable solutions also plays a crucial role[2].

Packaging Considerations for Norplant System

While the Norplant System itself is not packaged in plastic containers in the traditional sense (it involves subdermal implants), the broader trends in medical device packaging can influence how such products are stored and distributed.

• Sterility and Durability: Medical devices like the Norplant System require packaging that maintains sterility and protects the product from damage. Rotomolded containers, with their durability and weather resistance, could be an option for storing and transporting such devices.
• Regulatory Compliance: Any packaging solution must comply with strict regulatory frameworks, especially in the healthcare sector. This includes ensuring the material used is safe and does not contaminate the medical device.

Key Takeaways

• Clinical Efficacy: The combination of Norplant II and testosterone enanthate injections is highly effective in suppressing spermatogenesis for male contraception.
• Market Growth: The global plastic containers market, including rotomolded containers, is expected to grow significantly, driven by factors such as durability, cost-effectiveness, and sustainability.
• Packaging Considerations: Medical devices require packaging that ensures sterility and durability, and any solution must comply with regulatory standards.

FAQs

Q: What is the Norplant System, and how is it used for male contraception? A: The Norplant System involves levonorgestrel implants, which, when combined with androgens like testosterone, can suppress spermatogenesis for male contraception.

Q: How effective is the combination of Norplant II and testosterone enanthate injections in suppressing spermatogenesis? A: This combination is highly effective, achieving azoospermia in 93% of the subjects in clinical trials.

Q: What are the key drivers of the global rotomolded containers market? A: The market is driven by the durability, weather resistance, cost-effectiveness, and customization flexibility of rotomolded containers, as well as the increasing demand for sustainable solutions.

Q: How does the packaging of medical devices like the Norplant System align with broader market trends? A: Medical devices require packaging that maintains sterility and protects the product from damage, aligning with the benefits of rotomolded containers such as durability and weather resistance.

Q: What is the projected growth of the global plastic containers market? A: The global plastic containers market is expected to grow from $218.04 billion in 2024 to $344.79 billion by 2032, at a CAGR of 5.9%.

Sources

1. Gaw Gonzalo, I. T., et al. "Levonorgestrel Implants (Norplant II) for Male Contraception Clinical Trials: Combination with Transdermal and Injectable Testosterone." The Journal of Clinical Endocrinology & Metabolism, vol. 87, no. 8, 2002, pp. 3562–3572.
2. GlobeNewswire. "Global Rotomolded Containers Market to Reach USD 6.3 Billion by 2034, Driven by Demand for Sustainable Solutions - Future Market Insights, Inc."
3. RxList. "Norplant (Levonorgestrel Implants (Unavailable in US)) - RxList"
4. PubMed. "Levonorgestrel implants (Norplant II) for male contraception clinical trials."
5. Fortune Business Insights. "Plastic Containers Market Size, Share | Growth Report [2032]"

Last updated: 2024-12-31